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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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RANGER II SFA Cont F/u Study


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General
Study Status Progress Adequate
Application Number P190019 / PAS001
Date Current Protocol Accepted  
Study Name RANGER II SFA Cont F/u Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up of premarket cohort: RCT
Study Population Description Test: Ranger DCB

Control: PTA

Sample Size 376
Data Collection The primary effectiveness endpoint is primary patency of the target lesion at 24 months.



The primary safety endpoint is a composite of freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) at 24 months.



The endpoints to be assessed through 5 years post-procedure are rate of: (1) major adverse events (MAE), (2) clinically-driven target lesion revascularization (CD-TLR), (3) all TLR, (4) clinically-driven target vessel revascularization (CD-TVR), (5) target limb major amputation, (6) arterial thrombosis and (7) mortality status. The endpoints to be assessed at 2 and 3 years post-procedure are: (1) patency, (2) change in ankle-brachial index (ABI), (3) change in walking impairment questionnaire (WIQ), (4) change in walking distance, (5) change in Rutherford classification, and (6) change in quality of life assessment by EQ-5D questionnaire.

Follow-up Visits and Length of Follow-up 5 years


RANGER II SFA Cont F/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/30/2021 04/29/2021 On Time
one year report 10/30/2021    
18 month report 04/30/2022    
two year report 10/30/2022    


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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