The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)

Description

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.

Conditions

Peripheral Arterial Disease, Symptomatic Femoropopliteal Lesions

Study Overview

Study Details

Study 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.

Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients

The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)

Condition
Peripheral Arterial Disease
Intervention / Treatment

-

Contacts and Locations

Salinas

Salinas Valley Memorial Hospital, Salinas, California, United States, 93901

Storrs

University of Connecticut, Storrs, Connecticut, United States, 06269

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Delray Beach

Delray Medical Center, Delray Beach, Florida, United States, 33484

Boston

Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Kansas City

Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States, 64111

New York

NYU Langone Medical Center, New York, New York, United States, 10016

Cleveland

Cleveland Clinic Main Campus, Cleveland, Ohio, United States, 44195

West Chester

University of Pennsylvania, West Chester, Pennsylvania, United States, 19380

Wynnewood

Main Line Health, Wynnewood, Pennsylvania, United States, 19096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Endologix,

    Study Record Dates

    2032-06-07