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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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DETOUR2 Continued Follow-up Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P220021 / PAS001
Date Original Protocol Accepted 06/07/2023
Date Current Protocol Accepted  
Study Name DETOUR2 Continued Follow-up Study
Device Name DETOUR System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives To evaluate the long-term safety and effectiveness of the DETOUR System. The study is continued follow-up of the pivotal DETOUR 2 trial cohort (G170083). The premarket was a prospective, single arm, multicenter study that treated 220 subjects at 36 investigation sites.
Study Population All remaining subjects treated with the DETOUR System in the DETOUR 2 trial active at the time of 12 months evaluation. There is no comparator group.
Sample Size All 197 subjects remaining in the DETOUR 2 trial study at 12 months will be enrolled.
Key Study Endpoints Endpoints to be assessed at 24 and 36 months include

Major Adverse Events (MAE)
Symptomatic Deep Vein Thrombosis (DVT) on ipsilateral limb
Pulmonary embolism
Stent graft separation and migration identified via ultrasound imaging
Clinical Success defined as limb ischemia improvement as assessed by Rutherford Clinical Classification (improvement in scale by =1)
Limb ischemia by Rutherford Clinical - Classification
Primary Patency
Primary assisted patency
Secondary patency
Target Vessel Revascularization
Ankle-Brachial Index (ABI) or Toe Brachial Index (TBI) of both the index limb and contralateral limb
Major index limb amputations
Venous Clinical Severity Score and Villalta Scale
Follow-up Visits and Length of Follow-up 3 years


DETOUR2 Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/06/2023 12/07/2023 Overdue/Received
1 year report 06/06/2024    
2 year report 06/06/2025    
3 year report 06/06/2026    
4 year report 06/06/2027    


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

Additional Resources

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