Trial Outcomes & Findings for Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++) (NCT NCT00733135)
NCT ID: NCT00733135
Last Updated: 2015-08-26
Results Overview
Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory
COMPLETED
PHASE2/PHASE3
133 participants
at the end of the procedure
2015-08-26
Participant Flow
133 subjects were enrolled in this study between October 30, 2008 and October 13, 2010. The type of location included hospitals with catheterization labs and/or vascular centers.
Participant milestones
| Measure |
Study Cohort
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Overall Study
STARTED
|
133
|
|
Overall Study
COMPLETED
|
131
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Baseline characteristics by cohort
| Measure |
Study Cohort
n=133 Participants
All participants were treated with SilverHawk™ /TurboHawk™ plaque excision systems, with the SpiderFX™ embolic protection device placed distally.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
95 Participants
n=99 Participants
|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
133 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: at the end of the procedurePopulation: Number of lesions assessed by the angiographic core lab
Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory
Outcome measures
| Measure |
Study Cohort
n=163 lesions
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Successful Revascularization
|
92.0 percentage of lesions
Interval 87.6 to 95.2
|
PRIMARY outcome
Timeframe: 30 DaysMAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
Outcome measures
| Measure |
Study Cohort
n=131 Participants
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Major Adverse Event Free Rate 30 Days
|
93.1 percentage of participants
Interval 88.3 to 96.4
|
SECONDARY outcome
Timeframe: at the end of the procedurePopulation: Total patient population minus one patient because there was no angiographic post-treatment core lab data available.
Technical Procedural Success was defined as meeting all of the following requirements: * Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory * No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC) * No device malfunction causing the procedure to be aborted * Successful delivery and placement of the SpiderFX™ embolic protection device
Outcome measures
| Measure |
Study Cohort
n=132 Participants
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Technical Procedural Success
|
88.6 percentage of participants
|
SECONDARY outcome
Timeframe: at the end of the procedurePopulation: 1 lesion not included because there is no angiographic core laboratory post-treatment data available
This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.
Outcome measures
| Measure |
Study Cohort
n=167 lesions
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Residual Diameter Stenosis
|
64.1 percentage of lesions
|
SECONDARY outcome
Timeframe: at the end of the procedurePresence of debris in deployed SpiderFx™ embolic protection device
Outcome measures
| Measure |
Study Cohort
n=138 deployed filters
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Presence of Debris in Deployed SpiderFx™ Embolic Protection Device
|
88.4 percentage of deployed filters
|
SECONDARY outcome
Timeframe: at the end of the procedurePopulation: 115/133 subjects had the required angiographic images to assess this outcome.
Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.
Outcome measures
| Measure |
Study Cohort
n=115 Participants
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Preservation of Run-off Distal to the Filter
|
98.3 percentage of participants
|
Adverse Events
Study Cohort
Serious adverse events
| Measure |
Study Cohort
n=133 participants at risk
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Vascular disorders
Access Site AE
|
2.3%
3/133 • Number of events 3 • Through 30 days post-procedure
|
|
Vascular disorders
Amputation at or below metatarsal line
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
AV fistula, target vessel
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Dissection, grade A or B; target vessel
|
3.0%
4/133 • Number of events 4 • Through 30 days post-procedure
|
|
Vascular disorders
Dissection, grade D or greater; target vessel
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Distal embolism; plaque, thrombus (blood clot) or debris distal to the filter, clinically relevant
|
2.3%
3/133 • Number of events 3 • Through 30 days post-procedure
|
|
Gastrointestinal disorders
GI bleeding due to anticoagulation
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Hypotension or hypertension
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Myocardial infarction, acute
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Endocrine disorders
Renal insufficiency
|
1.5%
2/133 • Number of events 2 • Through 30 days post-procedure
|
|
Vascular disorders
Pseudoaneurysm, non-target vessel
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Target vessel revascularization; non-clinically driven
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Thrombosis (acute and subacute); target vessel
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Vascular disorders
Vessel clinical perforation, target vessel
|
2.3%
3/133 • Number of events 3 • Through 30 days post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Other, respiratory
|
0.75%
1/133 • Number of events 1 • Through 30 days post-procedure
|
|
Surgical and medical procedures
Other
|
5.3%
7/133 • Number of events 11 • Through 30 days post-procedure
|
Other adverse events
| Measure |
Study Cohort
n=133 participants at risk
All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally.
|
|---|---|
|
Vascular disorders
Access site adverse event
|
6.8%
9/133 • Number of events 10 • Through 30 days post-procedure
|
|
Vascular disorders
Dissection, grade A or B; target vessel
|
19.5%
26/133 • Number of events 26 • Through 30 days post-procedure
|
|
Vascular disorders
Other
|
18.0%
24/133 • Number of events 42 • Through 30 days post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can not make any publication concerning the study without providing the sponsor 30 days to review it and provide comments. The Sponsor may require PI to delay publication until any factual errors are corrected. If the sponsor determines the proposed publication contains confidential information, or patentable subject matter that requires protection, the sponsor may require delay of the publication less than or equal to 90 days.
- Publication restrictions are in place
Restriction type: OTHER