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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SUPERB Extended F/U Study


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General
Application Number P120020 / PAS001
Current Plan Approved 10/20/2014
Study Name SUPERB Extended F/U Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohorts
Study Population Description Subjects with SFA and proximal popliteal artery lesions treated with the Supera stent.

There is no comparator group.

Sample Size All remaining study subjects: 212 ITT subjects and 44 Roll-in

Subjects as of July 2013

Data Collection 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

Follow-up Visits and Length of Follow-up 3 years

2 and 3 years
Final Study Results
Number of Patients 264 subjects enrolled; 208 subjects were eligible for the 2-year PAS.
Number of Sites 46 Investigational Sites
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)
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%].
Strengths & Weaknesses The study achieved adequate compliance rate at 3 years (98.9% for the ITT population)
Label 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.


SUPERB Extended F/U Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 09/26/2014 11/17/2014 Overdue/Received
response to R1 RDEF-final report 05/15/2015 04/10/2015 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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