Evaluating the DETOUR System for treating blocked leg arteries
Prospective, Single Arm, Registry-based Study to Evaluate the Real-world Use of the DETOUR™ System in US Patients
This study is testing the DETOUR System to see if it can help people with blocked leg arteries who aren't good candidates for standard treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Endologix Industry-sponsored |
| Locations | 10 sites (Salinas, California and 9 other locations) |
| Trial ID | NCT06315023 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world application of the DETOUR System in patients suffering from symptomatic femoropopliteal lesions. It will enroll up to 450 participants, ensuring a balanced representation of both genders, and will follow them for up to five years post-procedure. The study will take place across a maximum of 200 sites that are part of the VQI PVI Registry, with follow-up assessments scheduled at various intervals to monitor outcomes. The focus is on patients who are considered suboptimal candidates for traditional surgical or endovascular treatments.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic femoropopliteal lesions who are assessed by their physician as suitable for the DETOUR System.
Not a fit: Patients who do not have symptomatic femoropopliteal lesions or are not considered candidates for the DETOUR System may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat peripheral arterial disease.
How similar studies have performed: While this approach is part of post-market surveillance, similar studies have shown promise in evaluating new vascular interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants should be a candidate for the DETOUR System as assessed by the treating physician after review of the clinical and anatomic Indications for Use. - Exclusion Criteria: There are no exclusion criteria. All cases entered in the registry at participating institutions will be included up through the targeted goals per the enrollment plan. -
Where this trial is running
Salinas, California and 9 other locations
- Salinas Valley Memorial Hospital — Salinas, California, United States (Recruiting)
- University of Connecticut — Storrs, Connecticut, United States (Recruiting)
- Medstar Washington Hospital Center — Washington, District of Columbia, United States (Recruiting)
- Delray Medical Center — Delray Beach, Florida, United States (Recruiting)
- Beth Isreal Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Recruiting)
- NYU Langone Medical Center — New York, New York, United States (Recruiting)
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania — West Chester, Pennsylvania, United States (Recruiting)
- Main Line Health — Wynnewood, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Tammy Stiver
- Email: tstiver@endologix.com
- Phone: 5136731452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.