The DETOUR 2 Clinical Trial

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Key facts

Study ID

NCT03119233

Run by

Endologix

People needed

202

Starts

2017-12-13

Expected to finish

2023-11-13

Last updated by the study team

2025-04-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study:
• General Inclusion Criteria
• Age > 18 and ≤ 90 years of age.
• Willing and able to provide informed consent.
• Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
• Clinical Inclusion Criteria
• Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5.
• Venous Clinical Severity Score < 3.
• Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
• Angiographic Inclusion Criteria
• Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), by investigator visual assessment.
• Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment.
• Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone
• Able to successfully access the SFA origin for entry of the crossing device.
• At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot.
• A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.
• General Exclusion Criteria
• Participating in another investigational clinical study.
• Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial.
• Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
• Clinical Exclusion Criteria
• History of deep vein thrombosis on either limb.
• Thrombophlebitis, within the previous 30 days.
• 6. Planned major amputation of the target limb, including minor amputation (above the ankle).
• Prior distal amputation (above the transmetatarsal) of the target limb.

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• St. Bernard's Medical Center — Jonesboro, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Bay Area Vein and Vascular — Burlingame, California, United States
• Community Hospital of the Monterrey Peninsula — Monterey, California, United States
• Advanced Cardiovascular Specialists — Mountain View, California, United States
• Denver VA Medical Center — Denver, Colorado, United States
• The Vascular Experts — Darien, Connecticut, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Baptist Hospital Miami — Miami, Florida, United States
• Christie Clinic — Champaign, Illinois, United States
• AMITA Health Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• McLaren Bay Region Hospital — Bay City, Michigan, United States
• Advanced Cardiac and Vascular Amputation Prevention Centers — Grandville, Michigan, United States
• Cardiac & Vascular Research Center of Nothern Michigan — Petoskey, Michigan, United States
• Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• New York-Presbyterian / Columbia University Medical Center — New York, New York, United States
• North Caroline Hearth and Vascular- University of North Carolina Rex — Raleigh, North Carolina, United States
• The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education — Cincinnati, Ohio, United States
• Cleveland Clinical Foundation — Cleveland, Ohio, United States
• Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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