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The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
Sponsor: Endologix
Summary
The purpose of this post-market surveillance study will be to evaluate the real-world use of the DETOUR System in treated patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis \> 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments.
Official title: Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
450
Start Date
2023-10-06
Completion Date
2032-06-07
Last Updated
2025-05-11
Healthy Volunteers
No
Interventions
DETOUR System
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Locations (10)
Salinas Valley Memorial Hospital
Salinas, California, United States
University of Connecticut
Storrs, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Delray Medical Center
Delray Beach, Florida, United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
University of Pennsylvania
West Chester, Pennsylvania, United States
Main Line Health
Wynnewood, Pennsylvania, United States