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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120020 / PAS001 |
| Date Original Protocol Accepted |
03/28/2014
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| Date Current Protocol Accepted |
10/20/2014
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| Study Name |
SUPERB Extended F/U Study
|
| Device Name |
SUPERA PERIPHERAL STENT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohorts
|
| Study Population |
Subjects with SFA and proximal popliteal artery lesions treated with the Supera stent.
There is no comparator group.
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| Sample Size |
All remaining study subjects: 212 ITT subjects and 44 Roll-in
Subjects as of July 2013
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| Key Study Endpoints |
Safety Endpoint
Composite of amputation and clinically-driven target lesion revascularization (TLR) evaluated at 2 and 3 years.
Secondary Endpoints include
Clinically driven TLR through 3 years
Stent Fracture Rate at 2 and 3 years by X-ray evaluation
Core Laboratory, defined as type I, II, III, IV or V. Composite endpoint of Death, Amputation and TLR Adverse and Serious Adverse events through 3 years.
Unanticipated Adverse Device Effect (UADE) through 3 years
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| Follow-up Visits and Length of Follow-up |
3 years
2 and 3 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
264 subjects enrolled; 208 subjects were eligible for the 2-year PAS.
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| Actual Number of Sites Enrolled |
46 Investigational Sites
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| Patient Follow-up Rate |
Follow-up rate- (ITT population) - Compliance rate at 36 months was 98.9% (177/179) Follow-up rate- (Roll-in population) - Compliance rate at 36 months was 100% (39/39)
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| Final Safety Findings |
(ITT Population)
Primary Endpoint
The long term composite safety endpoint of clinically driven TLR and Index limb amputation at
36 months was 22.3% (41/184) [ 95% CI:16.5%,29.0%].
Secondary Endpoints
The clinically driven TLR rate at 36 months was 21.3% (39/183) [95% CI: 15.6%, 28.0%].
The safety composite secondary endpoint (Death at 1 month, TLR, Index limb Amputation and RB Classification increase by 2 classes at 36 months) event rate at 36 months was 24.16% (43/178) [95% CI: 18.07%, 31.13%].
The index limb amputation at 36 months was 1.2% (2/173) [95% CI: 0.1%,4.1%], and Rutherford
Becker classification increase by 2 classes as compared to pre-procedure at 36 months was
1.20% (2/167) [0.15%,4.26%].
Stent fracture rate at 36 months was 0.6% (1/162) [95% CI: 0.0%, 3.4%].
The proportion of patients with any adverse event and any serious adverse event through 36 months cumulative was 97.2% (211/217) and 91.5% (151/165), respectively.
There were no unanticipated adverse device effect events reported through 3 years.
Major adverse vascular event (MAVE) rate at 36 months was 6.3% (11/175) [95% CI: 3.2%,
11.0%]
Target Vessel Revascularization at 36 Months was 25.8% (48/186) [95% CI: 19.7%, 32.7%].
(Roll-in Population) Secondary Endpoints
The long term composite safety endpoint of clinically driven TLR and Index limb amputation at
36 months was 27.9% (12/43) [95% CI: 15.3%, 43.7%].
Clinically driven TLR rate at 36 months was 26.2% (11/42) [95% CI: 13.9%, 42.0%].
The safety composite secondary endpoint (Death at 1 month, TLR, Index limb Amputation and RB Classification increase by 2 classes at 36 months) event rate at 36 months was 29.27% (12/41) [ 95% CI: 16.13%,45.54%].
The index limb amputation at 36 months was 2.5% (1/40) [95% CI: [95% 0.1%,13.2%], and Rutherford Becker classification increase by 2 classes as compared to pre-procedure at 36 months was 0.0% (0/37) [95% CI: 0.00%, 9.49%].
The Stent fracture rate at 36 months was 0% (0/31).
The proportion of patients with any adverse event and any serious adverse event through 36 months cumulative was 98.1% (51/52) and 85.7% (36/42), respectively.
There were no unanticipated adverse device effect events reported through 3 years. Major adverse vascular event (MAVE) rate at 36 months was 5.0% [95% CI: 0.6%, 16.9%]
Target Vessel Revascularization at 36 Months was 32.6% (48/186) [95% CI: 19.1%, 48.5%].
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| Study Strengths & Weaknesses |
The study achieved adequate compliance rate at 3 years (98.9% for the ITT population)
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the 3-year long term results from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow ¿up visits etc.), results and study strengths and limitations.
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