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RecruitingNCT06315023

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

Sponsor

Endologix

Enrollment

450 participants

Start Date

Oct 6, 2023

Study Type

OBSERVATIONAL

Conditions

Peripheral Arterial DiseaseSymptomatic Femoropopliteal Lesions

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 Criteria1

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Exclusion Criteria1

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Interventions

DEVICEDETOUR 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

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NCT06315023

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