Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
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Locations
United States
California
Salinas Valley Memorial Hospital
RECRUITING
Salinas
Connecticut
University of Connecticut
RECRUITING
Storrs
Washington, D.c.
Medstar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Delray Medical Center
RECRUITING
Delray Beach
Massachusetts
Beth Isreal Deaconess Medical Center
RECRUITING
Boston
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
New York
NYU Langone Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
West Chester
Main Line Health
RECRUITING
Wynnewood
Contact Information
Primary
Tammy Stiver
tstiver@endologix.com
5136731452
Time Frame
Start Date: 2023-10-06
Estimated Completion Date: 2032-06-07
Participants
Target number of participants: 450
Treatments
As Treated
All patients that have received the therapy; patients treated within and outside the IFU criteria subgroups; male and female subgroups; and duplex imaging subgroups for arterial and venous observations.
Imaging Cohort
Sites that are performing (arterial and venous) duplex ultrasound assessments according to the institution's standard practice will be asked to participate in the DUS imaging cohort. The Imaging sub-study will consist of 55 female and 55 male subjects from these sites. Duplex imaging at 1-, 12-, 24-, and 36-months post-procedure will be collected to assess the endpoints of graft patency and venous thrombus within the vein containing the graft (n=110).
Related Therapeutic Areas
Sponsors
Collaborators: Massachusetts General Hospital, Fivos, Society for Vascular Surgery Patient Safety Organization
Leads: Endologix