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The DETOUR 2 Clinical Trial | Clinical Trials | Clareo Health

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The DETOUR 2 Clinical Trial

The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial

NCT03119233•Endologix

Summary

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.

Detailed Description

The DETOUR2 study is a prospective, single-arm, multi-center, international, non-randomized, safety and effectiveness clinical investigation of the PQ Bypass system. The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to 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), with reference vessel diameters ranging from 5.0 - 6.7 mm, by investigator visual assessment.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \> 18 and ≤ 90 years of age.
•2. Willing and able to provide informed consent.
•3. Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
•4. Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5.
•5. Venous Clinical Severity Score \< 3.
•6. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
•7. 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.
•8. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment.
•9. Subject has a patent popliteal artery (\<50% stenosis) distal to the landing zone
•10. Able to successfully access the SFA origin for entry of the crossing device.
+2 more criteria

Exclusion Criteria

•1. Participating in another investigational clinical study.
•2. 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.
•3. 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.
•4. History of deep vein thrombosis on either limb.
•5. Thrombophlebitis, within the previous 30 days.
•6. 6\. Planned major amputation of the target limb, including minor amputation (above the ankle).
•7. Prior distal amputation (above the transmetatarsal) of the target limb.
•8. Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome \[SIRS\])
•9. Rutherford clinical category 0, 1, 2 or 6.
•10. Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine \>2.5mg/dL (220µmol/L) or on dialysis.
+10 more criteria

Locations (34)

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

Key Dates

Start Date

December 13, 2017

Primary Completion Date

December 22, 2021

Completion Date

November 13, 2023

Last Updated

April 2, 2025

Enrollment

202

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

DETOUR System

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The DETOUR 2 Clinical Trial

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

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