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

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New Enrollment IN.PACT AV Access PAS


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General
Study Status Progress Adequate
Application Number P190008 / PAS002
Date Current Protocol Accepted 06/24/2020
Study Name New Enrollment IN.PACT AV Access PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The new enrollment IN.PACT AV Access Post Approval Study is a Condition of Approval for the IN.PACT AV device. It is a prospective, non-randomized, multi-center, single-arm post-approval study in the United States. that is intended to assess the long term safety and performance of the

IN.PACT AV DCB in a U.S. population. There are two cohorts. The objectives of the primary cohort is to demonstrate the 1-year infection and infestation rate and the mortality rate out to 5 years. An extended cohort will also be enrolled to obtain real-world experience regarding the rates of infection/infestation and mortality.

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 with reference vessel diameters of 4 to 12 mm.
Sample Size 240 subjects will be enrolled at up to 20 clinical sites in the

US, with an expected enrollment period of 18-24 months. In the primary cohort, a sample size of up to 160 patients will be enrolled to ensure 125 patients complete follow-up through 1-year. Up to 80 patients will be evaluated in the extended cohort.



Data Collection Primary Cohort:

The primary cohort is designed to meet a performance goal of 30% for Serious Adverse Events defined as site reported serious adverse events MedDRA coded to the “infection and infestations” SOC through 1-year post-index procedure. The study will also collect information on the mortality rate out to 5 years.



Extended Cohort:

An extended cohort will also be enrolled to obtain real-world experience regarding the rates of infection/infestation and mortality out to 5 years.

Follow-up Visits and Length of Follow-up Patients will be followed up to 60 months post-index procedure.


New Enrollment IN.PACT AV Access PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/21/2020 05/15/2020 On Time
one year report 11/20/2020    
two year report 11/20/2021    
three year report 11/20/2022    
four year report 11/20/2023    
five year report 11/20/2024    


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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