RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-06
Study Completion:2032-06-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06315023

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Tammy Stiver
CONTACT
5136731452
tstiver@endologix.com

Study Locations (Sites)

Salinas Valley Memorial Hospital
Salinas, California, 93901
United States
University of Connecticut
Storrs, Connecticut, 06269
United States
Medstar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Delray Medical Center
Delray Beach, Florida, 33484
United States
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
NYU Langone Medical Center
New York, New York, 10016
United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
United States
University of Pennsylvania
West Chester, Pennsylvania, 19380
United States
Main Line Health
Wynnewood, Pennsylvania, 19096
United States

Collaborators and Investigators

Sponsor: Endologix

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-06
Study Completion Date2032-06-07

Study Record Updates

Study Start Date2023-10-06
Study Completion Date2032-06-07

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease
  • Symptomatic Femoropopliteal Lesions