RECRUITINGOBSERVATIONAL
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify: Participants should be a candidate for the DETOUR System as assessed by the treating physician after review of the clinical and anatomic Indications for Use.
\-
Who Should NOT Join This Trial: There are no exclusion criteria. All cases entered in the registry at participating institutions will be included up through the targeted goals per the enrollment plan.
\-
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria: Participants should be a candidate for the DETOUR System as assessed by the treating physician after review of the clinical and anatomic Indications for Use.
\-
Exclusion Criteria: There are no exclusion criteria. All cases entered in the registry at participating institutions will be included up through the targeted goals per the enrollment plan.
\-
Treatments Being Tested
DEVICE
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