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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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PAS 2 (New Enroll. of Female Pat. Study)

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Study Status Progress Adequate
Application Number P130024 / PAS002
Date Current Protocol Accepted 02/06/2018
Study Name PAS 2 (New Enroll. of Female Pat. Study)
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, multicenter, single-arm study.

To evaluate the safety and effectiveness of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries in the US female population.

Study Population Description US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per IFU with the Lutonix Catheter.
Sample Size Approximately 165 patients will be enrolled at a minimum of 10 US centers and a maximum of 25.

This sample size was selected based on precision (width of the confidence interval) for the primary endpoint. Assuming a response rate of 65%, the primary patency success rate observed in the LEVANT 2 pivotal study for DCB subjects, the expected two-sided exact confidence interval is (56.5%, 72.9%) which provides less than +/- 10% around the estimate (91/140 = 65%).

Data Collection The primary safety endpoint is the composite of freedom from all-cause peri-operative (less than or equal to 30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb- related death.

The primary effectiveness endpoint is primary patency of the target lesion at 12 months. Primary patency is defined as Freedom from target lesion restenosis (TLR) and from Binary Restenosis. Binary Restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) greater than or equal to 2.5 and / or abnormal waveforms, or based on angiographic greater than or equal to 50% diameter stenosis.

Secondary endpoints that will be assessed at 1 month:

Composite of freedom from all-cause perioperative (less than or equal to 30 day) death and freedom from the following: index limb amputation, index limb reintervention, and index-limb- related death.

Major Vascular Complications (<30 days)

Secondary endpoints that will be assessed at 1, 6, 12 and 24 months:

All-cause death

Clinically driven TLR

Target Vessel Revascularization (TVR)

Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature

Rate of unanticipated and anticipated device-related serious adverse events

Amputation (above the ankle)-Free Survival (AFS)

Change of Rutherford classification from baseline

Sustained Clinical Benefit (improvement in Rutherford Class compared to baseline AND freedom from target vessel revascularization)

Change of resting Ankle Brachial Index (ABI) from baseline

Follow-up Visits and Length of Follow-up 24 months

1, 6, 12, and 24 Months

PAS 2 (New Enroll. of Female Pat. Study) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/09/2015 04/10/2015 Overdue/Received
one year report 10/09/2015 10/09/2015 On Time
18 month report 04/08/2016 04/08/2016 On Time
two year report 10/08/2016 10/11/2016 Overdue/Received
three year report 10/08/2017 10/11/2017 Overdue/Received
interim report 04/08/2018 04/04/2018 On Time
four year report 10/08/2018 10/05/2018 On Time
interim report 04/08/2019    
five year report 10/08/2019    
six year report 10/08/2020    
final report 05/28/2021    

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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