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

Part of paid clinical trials in Salinas, California.

Sponsor
Endologix
Study ID
NCT06315023
Status
Enrolling By Invitation

Conditions

  • Peripheral Arterial Disease
  • Symptomatic Femoropopliteal Lesions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • DETOUR System — DEVICE
    Percutaneous Transmural Arterial Bypass Therapy using the DETOUR™ System

Study Details

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.

Key Dates

Start date
Oct 6, 2023
Status verified
May 2026
Primary completion
Jun 7, 2028
Completion
Jun 7, 2032

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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).

Primary Outcome Measure

Freedom from CD-TLR [ Time Frame: 1 Year ]

Locations (10)

FacilityCityStateZIPSite coordinators
Salinas Valley Memorial HospitalSalinasCalifornia93901-
University of ConnecticutStorrsConnecticut06269-
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010-
Delray Medical CenterDelray BeachFlorida33484-
Beth Isreal Deaconess Medical CenterBostonMassachusetts02215-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
NYU Langone Medical CenterNew YorkNew York10016-
Cleveland Clinic Main CampusClevelandOhio44195-
University of PennsylvaniaWest ChesterPennsylvania19380-
Main Line HealthWynnewoodPennsylvania19096-

Find similar trials in Salinas, CA

By research site
Salinas Valley Memorial Hospital· Salinas, CAUniversity of Connecticut· Storrs, CTMedstar Washington Hospital Center· Washington D.C., DCDelray Medical Center· Delray Beach, FLBeth Isreal Deaconess Medical Center· Boston, MASaint Luke's Hospital of Kansas City· Kansas City, MO

Related Studies