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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Surveillance Post Market Registry

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Study Status Completed
Application Number /
Requirement Number
P140010 S015/ PAS001
Date Original Protocol Accepted 12/06/2016
Date Current Protocol Accepted  
Study Name Surveillance Post Market Registry
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To assess the long-term safety and performance of the IN.PACT Admiral DCB in a U.S. population for the treatment of in-stent restenosic (ISR) lesions in the superficial femoral and popliteal arteries.
Prospective, non-randomized, multi-center, single-arm post-market registry
Study Population Patients from the U.S. with ISR lesions in the superficial femoral and popliteal arteries who have symptoms of claudication and/or rest pain (Rutherford Class 2, 3, or 4) who were entered into the VQI PVI Registry and met all other inclusion and exclusion criteria.
Sample Size 300 patients from the SVS VQI Registry, treated with the IN.PACT Admiral DCB per the standard of care, will be extracted consecutively and analyzed to evaluate the safety and performance of the IN.PACT Admiral DCB in a U.S. population for the treatment of ISR lesions in the femoropopliteal artery.
According to literature research on the performance of DCB in the treatment of ISR femoropopliteal lesions, the 12-month TLR rate for IN.PACT Admiral DCB treatment is expected to be 16%. Assuming 10% attrition at the 12-month follow-up, with 270 evaluable patients, the precision of the assumed 16% point estimate can be assessed by calculating the difference from the 1-sided 95% upper confidence limit. This difference, or margin of error, is calculated to be 4.1%.
Key Study Endpoints Primary:
Target lesion revascularization (TLR) within 12 months post-index procedure.
1. All-cause mortality at 12 months and 24 months.
2. Target lesion revascularization (TLR) at 24 months.
3. Target vessel revascularization (TVR) at 12 months and 24 months.
4. Major target limb amputation at 12 months and 24 months.
Follow-up Visits and Length of Follow-up 36 months
Interim or Final Data Summary
Actual Number of Patients Enrolled 300
Actual Number of Sites Enrolled 50
Patient Follow-up Rate 78%
Final Safety Findings Primary Safety Endpoint:
Target lesion revascularization (TLR) within 12 months post-index
procedure = 10.1% (28/276); Kaplan-Meier estimate of 10.2% with a 95%
confidence interval of [7.1%, 14.5%].
Secondary Safety Endpoints:
• All-cause mortality at 12, 24, and 36 months = 4.7% (14/299),
10.7% (32/298), and 15.5% (45/291), respectively
• Target lesion revascularization at 24 and 36 months = 29.2%
(71/243) and 45.9% (89/194)
• Target vessel revascularization at 12, 24, and 36 months =
12.0% (33/276), 33.3% (82/246), and 49.5% (99/200),
• Major target limb amputation at 12, 24, and 36 months = 0.4%
(1/275), 1.3% (3/237), and 1.7% (3/173), respectively
Final Effect Findings Technical success, defined as successful deployment of the balloon
without resulting in occlusion and having residual stenosis 30%
and resting systolic pressure gradient < 10 mmHg (if measured), was
achieved in 98.7% (296/300) of patients
Study Strengths & Weaknesses Strengths:
This PAS followed subjects through 3 years in a real-world, registry, setting. The trial met its study goals and results demonstrate long-term safety and effectiveness of the IN.PACT Admiral DCB in the treatment of in-stent restenosis lesions in the superficial femoral and popliteal arteries up to 36-months follow-up post-index procedure.
The study lacked a comparison group. There was less than 80% patient follow up rate at 3-years. The compliance data did not include "lost to follow-up" metrics.
Recommendations for Labeling Changes A labeling update will be requested to include the 3 year data to
support treatment of in-stent restenotic lesio

Surveillance Post Market Registry Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 03/08/2017 03/03/2017 On Time
1 year report 09/07/2017 09/01/2017 On Time
18 month report 03/08/2018 03/05/2018 On Time
2 year report 09/07/2018 09/06/2018 On Time
3 year report 09/07/2019 09/05/2019 On Time
4 year report 09/06/2020 09/03/2020 On Time
5 year report 09/06/2021 09/02/2021 On Time
6 year report 09/06/2022 09/02/2022 On Time
final report 09/06/2023 06/13/2023 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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