Trial Outcomes & Findings for Multi-center Study for Stent Graft System for Peripheral Artery (NCT NCT01575808)
NCT ID: NCT01575808
Last Updated: 2023-05-12
Results Overview
Primary Efficacy Endpoint \> \> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
133 participants
Primary outcome timeframe
12 months
Results posted on
2023-05-12
Participant Flow
133 participants were enrolled into the GP1101 arm; 14 were training cases, 16 were excluded by the Case Conference Committee; total participants started was 103. Retrospective Surgical Bypass Outcomes represent historical controls (n=68).
Participant milestones
| Measure |
GP1101
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular Device Implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
68
|
|
Overall Study
COMPLETED
|
100
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
GP1101
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular Device Implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Height was not measured in the Retrospective Surgical Bypass Outcomes arm
Baseline characteristics by cohort
| Measure |
GP1101
n=103 Participants
Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
|
Retrospective Surgical Bypass Outcomes
n=68 Participants
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 7.0 • n=103 Participants
|
72.3 years
STANDARD_DEVIATION 8.3 • n=68 Participants
|
73.4 years
STANDARD_DEVIATION 7.6 • n=171 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=103 Participants
|
17 Participants
n=68 Participants
|
35 Participants
n=171 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=103 Participants
|
51 Participants
n=68 Participants
|
136 Participants
n=171 Participants
|
|
Region of Enrollment
Japan
|
103 participants
n=103 Participants
|
68 participants
n=68 Participants
|
171 participants
n=171 Participants
|
|
Height
|
161.9 centimeter
STANDARD_DEVIATION 8.48 • n=103 Participants • Height was not measured in the Retrospective Surgical Bypass Outcomes arm
|
—
|
161.9 centimeter
STANDARD_DEVIATION 8.48 • n=103 Participants • Height was not measured in the Retrospective Surgical Bypass Outcomes arm
|
|
Weight
|
59.2 kilograms
STANDARD_DEVIATION 10.03 • n=103 Participants • Weight was not measured in the Retrospective Surgical Bypass Outcomes arm
|
—
|
59.2 kilograms
STANDARD_DEVIATION 10.03 • n=103 Participants • Weight was not measured in the Retrospective Surgical Bypass Outcomes arm
|
|
BMI
|
22.5 kg/㎡
STANDARD_DEVIATION 2.83 • n=103 Participants • BMI was not measured in the Retrospective Surgical Bypass Outcomes arm
|
—
|
22.5 kg/㎡
STANDARD_DEVIATION 2.83 • n=103 Participants • BMI was not measured in the Retrospective Surgical Bypass Outcomes arm
|
|
Smoking History
Current Smoker
|
29 Participants
n=103 Participants
|
23 Participants
n=68 Participants
|
52 Participants
n=171 Participants
|
|
Smoking History
Not a Current Smoker
|
74 Participants
n=103 Participants
|
45 Participants
n=68 Participants
|
119 Participants
n=171 Participants
|
|
Diabetes Mellitus
History of Diabetes Mellitus = Yes
|
62 Participants
n=103 Participants
|
34 Participants
n=68 Participants
|
96 Participants
n=171 Participants
|
|
Diabetes Mellitus
History of Diabetes Mellitus = No
|
41 Participants
n=103 Participants
|
34 Participants
n=68 Participants
|
75 Participants
n=171 Participants
|
|
Hypertension
History of Hypertension = Yes
|
91 Participants
n=103 Participants
|
59 Participants
n=68 Participants
|
150 Participants
n=171 Participants
|
|
Hypertension
History of Hypertension = No
|
12 Participants
n=103 Participants
|
9 Participants
n=68 Participants
|
21 Participants
n=171 Participants
|
|
Dyslipidemia
History of Dyslipidemia = Yes
|
64 Participants
n=103 Participants
|
32 Participants
n=68 Participants
|
96 Participants
n=171 Participants
|
|
Dyslipidemia
History of Dyslipidemia = No
|
39 Participants
n=103 Participants
|
36 Participants
n=68 Participants
|
75 Participants
n=171 Participants
|
|
Carotid Disease
History of Carotid Disease = Yes
|
13 Participants
n=103 Participants
|
6 Participants
n=68 Participants
|
19 Participants
n=171 Participants
|
|
Carotid Disease
History of Carotid Disease = No
|
90 Participants
n=103 Participants
|
62 Participants
n=68 Participants
|
152 Participants
n=171 Participants
|
|
Coronary Artery Disease
History of Coronary Artery Disease = Yes
|
42 Participants
n=103 Participants
|
21 Participants
n=68 Participants
|
63 Participants
n=171 Participants
|
|
Coronary Artery Disease
History of Coronary Artery Disease = No
|
61 Participants
n=103 Participants
|
47 Participants
n=68 Participants
|
108 Participants
n=171 Participants
|
|
Myocardial Infarction
History of Myocardial Infarction = Yes
|
12 Participants
n=103 Participants
|
7 Participants
n=68 Participants
|
19 Participants
n=171 Participants
|
|
Myocardial Infarction
History of Myocardial Infarction - No
|
91 Participants
n=103 Participants
|
61 Participants
n=68 Participants
|
152 Participants
n=171 Participants
|
|
Congestive Heart Failure
History of Congestive Heart Failure = Yes
|
4 Participants
n=103 Participants
|
3 Participants
n=68 Participants
|
7 Participants
n=171 Participants
|
|
Congestive Heart Failure
HIstory of Congestive Heart Failure = No
|
99 Participants
n=103 Participants
|
65 Participants
n=68 Participants
|
164 Participants
n=171 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
History of COPD = Yes
|
10 Participants
n=103 Participants
|
4 Participants
n=68 Participants
|
14 Participants
n=171 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
History of COPD = No
|
93 Participants
n=103 Participants
|
64 Participants
n=68 Participants
|
157 Participants
n=171 Participants
|
|
Study Limb
Right
|
56 Participants
n=103 Participants
|
32 Participants
n=68 Participants
|
88 Participants
n=171 Participants
|
|
Study Limb
Left
|
47 Participants
n=103 Participants
|
36 Participants
n=68 Participants
|
83 Participants
n=171 Participants
|
|
Ankle Brachial Index (ABI)
|
0.64 Ratio
STANDARD_DEVIATION 0.12 • n=102 Participants • Eligibility met by TBI for one subject.
|
0.47 Ratio
STANDARD_DEVIATION 0.20 • n=68 Participants • Eligibility met by TBI for one subject.
|
0.57 Ratio
STANDARD_DEVIATION 0.18 • n=170 Participants • Eligibility met by TBI for one subject.
|
|
Rutherford Category
Category 0 - Asymptomatic
|
0 Participants
n=103 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=171 Participants
|
|
Rutherford Category
Category 1 - Mild Claudication
|
0 Participants
n=103 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=171 Participants
|
|
Rutherford Category
Category 2 - Moderate Claudication
|
45 Participants
n=103 Participants
|
7 Participants
n=68 Participants
|
52 Participants
n=171 Participants
|
|
Rutherford Category
Category 3 - Severe Claudication
|
55 Participants
n=103 Participants
|
44 Participants
n=68 Participants
|
99 Participants
n=171 Participants
|
|
Rutherford Category
Category 4 - Ischemic Rest Pain
|
1 Participants
n=103 Participants
|
7 Participants
n=68 Participants
|
8 Participants
n=171 Participants
|
|
Rutherford Category
Category 5 - Minor Tissue Loss
|
2 Participants
n=103 Participants
|
10 Participants
n=68 Participants
|
12 Participants
n=171 Participants
|
|
Rutherford Category
Category 6- Major Tissue Loss
|
0 Participants
n=103 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=171 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPrimary Efficacy Endpoint \> \> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion
Outcome measures
| Measure |
GP1101
n=100 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Primary Assisted Patency
|
91 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to dischargeDuration (in days) of post-procedure hospital stay
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
n=68 Participants
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Duration of Stay
|
2.0 Days
Interval 2.0 to 3.0
|
12.5 Days
Interval 10.0 to 14.0
|
PRIMARY outcome
Timeframe: Day 0Percentage of study subjects avoiding general anesthesia
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
n=68 Participants
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Rate of Avoidance of General Anesthesia
|
103 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 1 monthComposite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure.
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)
|
103 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Kaplan-Meier estimate done at end of follow-up visit window
% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Percent of Participants Not Experiencing an Adverse Event
|
97.1 percent of participants
Interval 91.2 to 99.1
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months.
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Percent of Participants Not Experiencing an Adverse Event
|
97.1 Percent of participants
Interval 91.2 to 99.1
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Percent of Participants Not Experiencing an Adverse Event
|
95.1 percent of participants
Interval 88.7 to 97.9
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Percent of Participants Not Experiencing an Adverse Event
|
90.9 percent of participants
Interval 82.3 to 95.4
|
—
|
SECONDARY outcome
Timeframe: 24 months% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 months% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 months% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-procedurePlacement of GP1101 with residual stenosis of less than 30%
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Technical Success
|
102 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Primary Patency
|
99.0 Probability of having an event
Interval 93.2 to 99.9
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Primary Patency
|
97.1 Probability of having an event
Interval 91.2 to 99.0
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Primary Patency
|
92.1 Probability of having an event
Interval 84.8 to 96.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Primary Patency
|
92.1 Probability of having an event
Interval 84.8 to 96.0
|
—
|
SECONDARY outcome
Timeframe: 24 monthsHemodynamic blood flow through GP1101 that had not required a target lesion revascularization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Kaplan-Meier estimate done at end of follow-up visit window
No bypass surgery and no occlusion at the target site
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Secondary Patency
|
99.0 Probability of having an event
Interval 93.2 to 99.9
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
No bypass surgery and no occlusion at the target site
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Secondary Patency
|
98.0 Probability of having an event
Interval 92.4 to 99.5
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
No bypass surgery and no occlusion at the target site
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Secondary Patency
|
98.0 Probability of having an event
Interval 92.4 to 99.5
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
No bypass surgery and no occlusion at the target site
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Secondary Patency
|
98.0 Probability of having an event
Interval 92.4 to 99.5
|
—
|
SECONDARY outcome
Timeframe: 24 monthsNo bypass surgery and no occlusion at the target site
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Kaplan-Meier estimate done at end of follow-up visit window
X-ray for stent fracture evaluated by Core Lab
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Rate of Avoidance of Stent Fracture
|
100.0 Probability of having an event
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
X-ray for stent fracture evaluated by Core Lab
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Rate of Avoidance of Stent Fracture
|
100.0 Probability of having an event
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
X-ray for stent fracture evaluated by Core Lab
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Rate of Avoidance of Stent Fracture
|
100.0 Probability of having an event
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
X-ray for stent fracture evaluated by Core Lab
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Rate of Avoidance of Stent Fracture
|
100.0 Probability of having an event
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 24 monthsX-ray for stent fracture evaluated by Core Lab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Avoidance of Target Lesion Revascularization
|
100.0 Probability of having an event
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Avoidance of Target Lesion Revascularization
|
99.0 Probability of having an event
Interval 93.2 to 99.9
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Avoidance of Target Lesion Revascularization
|
95.1 Probability of having an event
Interval 88.6 to 97.9
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Kaplan-Meier estimate done at end of follow-up visit window
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Avoidance of Target Lesion Revascularization
|
93.1 Probability of having an event
Interval 86.1 to 96.7
|
—
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthThe Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Clinical Success
|
100 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsThe Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.
Outcome measures
| Measure |
GP1101
n=102 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Clinical Success
|
98 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsThe Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.
Outcome measures
| Measure |
GP1101
n=102 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Clinical Success
|
97 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 monthsThe Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.
Outcome measures
| Measure |
GP1101
n=99 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Clinical Success
|
90 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 monthsThe Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presentedAnkle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Change in Ankle-Brachial Index From Baseline
|
0.98 ABI
Standard Deviation 0.118
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presentedAnkle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)
Outcome measures
| Measure |
GP1101
n=101 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Change in Ankle-Brachial Index From Baseline
|
0.97 ABI
Standard Deviation 0.137
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presentedAnkle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)
Outcome measures
| Measure |
GP1101
n=102 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Change in Ankle-Brachial Index From Baseline
|
0.95 ABI
Standard Deviation 0.137
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presentedAnkle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)
Outcome measures
| Measure |
GP1101
n=94 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Change in Ankle-Brachial Index From Baseline
|
0.94 ABI
Standard Deviation 0.171
|
—
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presentedAnkle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthVascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Vascular Quality of Life Questionnaire - VascuQOL
|
5.5 units on a scale
Standard Deviation 1.09
|
—
|
SECONDARY outcome
Timeframe: 3 monthsVascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.
Outcome measures
| Measure |
GP1101
n=101 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Vascular Quality of Life Questionnaire - VascuQOL
|
5.3 units on a scale
Standard Deviation 1.26
|
—
|
SECONDARY outcome
Timeframe: 6 monthsVascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.
Outcome measures
| Measure |
GP1101
n=102 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Vascular Quality of Life Questionnaire - VascuQOL
|
5.3 units on a scale
Standard Deviation 1.23
|
—
|
SECONDARY outcome
Timeframe: 12 monthsVascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.
Outcome measures
| Measure |
GP1101
n=94 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Vascular Quality of Life Questionnaire - VascuQOL
|
5.1 units on a scale
Standard Deviation 1.30
|
—
|
SECONDARY outcome
Timeframe: 24 monthsVascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of "Activity", "Symptom", "Pain", "Emotional" and "Social" scores as subscales. The total score is calculated as the average value of all scores.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthWIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.
Outcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Walking Impairment Questionnaire-WIQ
|
66.9 units on a scale
Standard Deviation 34.2
|
—
|
SECONDARY outcome
Timeframe: 3 monthsWIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.
Outcome measures
| Measure |
GP1101
n=101 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Walking Impairment Questionnaire-WIQ
|
63.9 units on a scale
Standard Deviation 34.0
|
—
|
SECONDARY outcome
Timeframe: 6 monthsWIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.
Outcome measures
| Measure |
GP1101
n=102 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Walking Impairment Questionnaire-WIQ
|
67.0 units on a scale
Standard Deviation 34.1
|
—
|
SECONDARY outcome
Timeframe: 12 monthsWIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.
Outcome measures
| Measure |
GP1101
n=94 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Walking Impairment Questionnaire-WIQ
|
64.0 units on a scale
Standard Deviation 34.5
|
—
|
SECONDARY outcome
Timeframe: 24 monthsWIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-ProcedureOutcome measures
| Measure |
GP1101
n=103 Participants
Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft \>
\> GP1101: Endovascular stent graft implantation
|
Retrospective Surgical Bypass Outcomes
Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion were established to be consistent with the experimental arm.
|
|---|---|---|
|
Rate of Avoidance of Blood Transfusion
|
103 Participants
|
—
|
Adverse Events
GP1101
Serious events: 47 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GP1101
n=103 participants at risk
Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Angina pectoris
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Angina pectoris aggravated
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Angina unstable
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Anginal attack
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Atrial fibrillation paroxysmal
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Cardiac failure congestive
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Coronary artery stenosis
|
2.9%
3/103
Adverse events were systematically reported on Case Report Forms
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Eye disorders
Bilateral cataracts
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Eye disorders
Cataract aggravated
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Eye disorders
Left cataract
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Eye disorders
Right cataract
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Gastrointestinal disorders
Acute gastritis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Gastrointestinal disorders
Enterocolitis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Gastrointestinal disorders
Haemorrhage of digestive tract
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Gastrointestinal disorders
Small intestinal ulcer haemorrhage
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Adverse drug reaction
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Arterial stent occlusion
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Chest pain
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Device occlusion
|
6.8%
7/103
Adverse events were systematically reported on Case Report Forms
|
|
Hepatobiliary disorders
Hepatic function disorder
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Immune system disorders
Allergic reaction to antibiotics
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Acute pneumonia
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Device related infection
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Infection
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Influenza A virus infection
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Periodontitis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Pneumonia
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Pulmonary aspergillosis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Chronic subdural haematoma
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
In-stent peripheral artery restenosis
|
9.7%
10/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Malleolar fracture
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Poisoning by hypnotic
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Investigations
CRP increased
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Investigations
Potassium abnormal
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Investigations
Sugar blood level increased
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Metabolism and nutrition disorders
Insulin hypoglycaemia
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Metabolism and nutrition disorders
Loss of control of blood sugar
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of lateral wall of oropharynx
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Nervous system disorders
Carotid artery occlusion
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Nervous system disorders
Carotid artery stenosis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Nervous system disorders
Cerebral infarction
|
1.9%
2/103
Adverse events were systematically reported on Case Report Forms
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Nervous system disorders
Syncope vasovagal
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Nervous system disorders
Transient ischaemic attack
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Renal and urinary disorders
Renal failure chronic aggravated
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial pneumonia
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Vascular disorders
Femoral artery occlusion
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Vascular disorders
Iliac artery stenosis
|
3.9%
4/103
Adverse events were systematically reported on Case Report Forms
|
|
Vascular disorders
Peripheral artery stenosis
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Vascular disorders
Thromboembolism
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
|
Vascular disorders
Vascular occlusion
|
0.97%
1/103
Adverse events were systematically reported on Case Report Forms
|
Other adverse events
| Measure |
GP1101
n=103 participants at risk
Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft
|
|---|---|
|
General disorders
Adverse drug reaction
|
9.7%
10/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Implant site pain
|
17.5%
18/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Pyrexia
|
7.8%
8/103
Adverse events were systematically reported on Case Report Forms
|
|
General disorders
Vessel puncture site pain
|
5.8%
6/103
Adverse events were systematically reported on Case Report Forms
|
|
Infections and infestations
Common cold
|
5.8%
6/103
Adverse events were systematically reported on Case Report Forms
|
|
Vascular disorders
Hypertension aggravated
|
6.8%
7/103
Adverse events were systematically reported on Case Report Forms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place