The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DETOUR System.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
Overview
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.
Detailed description
A maximum of 450 subjects will be enrolled with a target study population of at least 200 evaluable female and 200 evaluable male participants at the 12-month post-procedure follow-up visit. A maximum of 200 US sites. Sites will be selected that participate or will participate in the VQI PVI Registry. Follow up visits/assessments will be completed at 1, 12, 24-, 36-, 48-, and 60-months post-procedure. Study enrollment is expected to conclude over 4 years. Follow up data at 1 year is expected to conclude in 5 years from enrollment, with 5-year follow up expected to conclude in 9 years from enrollment.
Interventions
- Device DETOUR System
Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System
Primary outcome measures
- Freedom from CD-TLR [Time frame: 1 Year]
- Freedom from MAE [Time frame: 30 Days]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 10 centers
- Salinas Valley Memorial Hospital — Salinas
- University of Connecticut — Storrs
- Medstar Washington Hospital Center — Washington D.C.
- Delray Medical Center — Delray Beach
- Beth Isreal Deaconess Medical Center — Boston
- Saint Luke's Hospital of Kansas City — Kansas City
- NYU Langone Medical Center — New York
- Cleveland Clinic Main Campus — Cleveland
- … and 2 more centers
Identifiers
NCT: NCT06315023 · CP-0029