Clinical Trials in the USA / NCT06315023
Enrolling by invitation
Observational
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
NCT06315023 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Peripheral Arterial DiseaseSymptomatic Femoropopliteal Lesions
Investigational drug(s) / intervention(s)
DETOUR System
DETOUR System: Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Study 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.
Eligibility
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.
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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.
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Primary outcome measure(s)
- Freedom from CD-TLR — 1 Year
Primary Effectiveness outcome is patency as defined as Freedom from Clinical Driven Target Lesion Revascularization (CD-TLR) - Freedom from MAE — 30 Days
Primary Safety outcome is freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), and/or Major Amputation of the Treated Limb.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Salinas Valley Memorial Hospital | Salinas | California | |
| University of Connecticut | Storrs | Connecticut | |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | |
| Delray Medical Center | Delray Beach | Florida | |
| Beth Isreal Deaconess Medical Center | Boston | Massachusetts | |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | |
| NYU Langone Medical Center | New York | New York | |
| Cleveland Clinic Main Campus | Cleveland | Ohio | |
| University of Pennsylvania | West Chester | Pennsylvania | |
| Main Line Health | Wynnewood | Pennsylvania |
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06315023 on ClinicalTrials.gov ↗ ← All trials in the USA