Trial Outcomes & Findings for Bard® LifeStent® Vascular Stent Delivery System Study (NCT NCT01179984)
NCT ID: NCT01179984
Last Updated: 2018-11-08
Results Overview
Effectiveness: Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
At implantation (Day 0)
Results posted on
2018-11-08
Participant Flow
Participant milestones
| Measure |
PTA and Study Stent
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bard® LifeStent® Vascular Stent Delivery System Study
Baseline characteristics by cohort
| Measure |
Single-Arm
n=76 Participants
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=99 Participants
|
|
Age, Continuous
|
70.1 Years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
76 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
76 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At implantation (Day 0)Effectiveness: Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
Outcome measures
| Measure |
PTA and Study Stent
n=64 Stents
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
Acute Effectiveness: Percentage of Stents With Successful Delivery
|
100 percentage of stents
Interval 90.0 to 100.0
|
PRIMARY outcome
Timeframe: 30 day follow-upPopulation: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
Safety: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
Outcome measures
| Measure |
PTA and Study Stent
n=76 Participants
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.
|
75 percentage of freedom from events
|
SECONDARY outcome
Timeframe: 12 months post-index procedurePopulation: Primary Target Lesion Patency (TLP) at 12 months post-index procedure.
Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure
Outcome measures
| Measure |
PTA and Study Stent
n=65 Participants
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
Primary Target Lesion Patency
|
81.5 percentage of participants
|
Adverse Events
PTA and Study Stent
Serious events: 49 serious events
Other events: 70 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
PTA and Study Stent
n=76 participants at risk
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
Cardiac disorders
Other
|
18.4%
14/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Angina Pectoris
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Arterial Fibrillation
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Cardiac Failure
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Myocardial Infarction
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Gastrointestinal disorders
Other
|
6.6%
5/76 • Throughout follow-up of study period = 36 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
Other
|
25.0%
19/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
Arterial Restenosis
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
In-stent Arterial Restenosis
|
21.1%
16/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Other
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
6.6%
5/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Dyspnea
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Other
|
28.9%
22/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Arterial restenosis
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Arterial restenosis limb
|
2.6%
2/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Femoral arterial stenosis
|
7.9%
6/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Femoral Arterial Occlusion
|
6.6%
5/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Iliac Artery Stenosis
|
5.3%
4/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
In-stent arterial restenosis
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
9.2%
7/76 • Throughout follow-up of study period = 36 months
|
Other adverse events
| Measure |
PTA and Study Stent
n=76 participants at risk
The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
|
|---|---|
|
Vascular disorders
Other
|
52.6%
40/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Arterial restenosis
|
5.3%
4/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Arterial stenosis lim
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Femoral arterial stenosis
|
18.4%
14/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Femoral artery occlusion
|
7.9%
6/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Hematoma
|
5.3%
4/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Iliac artery stenosis
|
6.6%
5/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Intermittent claudication
|
10.5%
8/76 • Throughout follow-up of study period = 36 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
11.8%
9/76 • Throughout follow-up of study period = 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
13.2%
10/76 • Throughout follow-up of study period = 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.3%
4/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Other
|
31.6%
24/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.6%
5/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
4/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
7/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
Other
|
46.1%
35/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
5.3%
4/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
23.7%
18/76 • Throughout follow-up of study period = 36 months
|
|
Injury, poisoning and procedural complications
Post -procedural hematoma
|
19.7%
15/76 • Throughout follow-up of study period = 36 months
|
|
Infections and infestations
Other
|
11.8%
9/76 • Throughout follow-up of study period = 36 months
|
|
Infections and infestations
Pneumonia
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
General disorders
Other
|
14.5%
11/76 • Throughout follow-up of study period = 36 months
|
|
General disorders
Pyrexia
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Other
|
19.7%
15/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Angina pectoris
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Cardiac failure
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
|
Cardiac disorders
Myocardial infarction
|
3.9%
3/76 • Throughout follow-up of study period = 36 months
|
Additional Information
Associate Director of Clinical Affairs
Bard Peripheral Vascular
Phone: 480-379-2838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place