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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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IN.PACT AV Access IDE Cohort PAS

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Study Status Progress Adequate
Application Number P190008 / PAS001
Date Current Protocol Accepted 03/04/2022
Study Name IN.PACT AV Access IDE Cohort PAS
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The IN.PACT AV Access IDE Cohort Post Approval Study is a study that was initiated prior to device approval. It was designed as a prospective, global, randomized (1:1), multi-center clinical study that is ongoing at sites in the United States, New Zealand, and Japan.
Study Population Description Subjects with a de novo or non-stented restenotic obstructive lesion up to 100 mm in length, located in the native arteriovenous dialysis fistulae.
Sample Size 330 subjects randomized in a ratio of 1:1 to either the IN.PACT AV Access DCB (study arm) or a standard PTA balloon (control arm).
Data Collection The primary safety endpoint is defined as the serious adverse event (SAE) rate involving the AV access circuit through 30 days post-procedure. The primary effectiveness endpoint is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-index procedure.
Follow-up Visits and Length of Follow-up Patients will be followed up to 60 months post-index procedure.

IN.PACT AV Access IDE Cohort PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 11/20/2020 11/19/2020 On Time
2 year report 10/20/2021 10/13/2021 On Time
3 year report 10/20/2022    
4 year report 11/20/2023    

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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