The DETOUR 2 Clinical Trial

NCT03119233 | Completed Results DMC FDA Device

• 1 other identifier: STP 203
• Study Type: interventional
• Target: 202
• Locations: 3 countries
• Sites: 34

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary Patency

  Primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from DUS and no clinically-driven re-intervention within the stented segment.

  12 months

• Major Adverse Events at 30 Days

  Freedom from a Major Adverse Event (MAE) at 30 days post-procedure (defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery).

  30 days

Secondary Outcomes (3)

• Stent Graft Separation and Migration

  30 Days

• Stent Graft Separation and Migration Via 12-Month X-Ray

  12 Months

• Stent Graft Fracture Via 12-Month X-Ray

  12-Months

Study Arms (1)

Single-Arm

EXPERIMENTAL

This is a prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the DETOUR System, delivery guidewires, and implant stent grafts for percutaneous femoropoliteal bypass compared to Performance Goals (PG)

Device: DETOUR System

Interventions

DETOUR System DEVICE

The DETOUR System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C).

Single-Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• History of deep vein thrombosis on either limb.
• Thrombophlebitis, within the previous 30 days.
• \. Planned major amputation of the target limb, including minor amputation (above the ankle).
• Prior distal amputation (above the transmetatarsal) of the target limb.
• 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 \[SIRS\])
• Rutherford clinical category 0, 1, 2 or 6.
• 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.
• Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.
• Morbid obesity that does not allow for safe vascular access or imaging.
• Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR \> 1.8.
• Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion.
• Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.

Sponsors & Collaborators

• Endologix: lead

Study Sites (34)

HonorHealth

Scottsdale, Arizona, 85251, United States

Location

St. Bernard's Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Bay Area Vein and Vascular

Burlingame, California, 94010, United States

Location

Community Hospital of the Monterrey Peninsula

Monterey, California, 93940, United States

Location

Advanced Cardiovascular Specialists

Mountain View, California, 94040, United States

Location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Baptist Hospital Miami

Miami, Florida, 33176, United States

Location

Christie Clinic

Champaign, Illinois, 61822, United States

Location

AMITA Health Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

McLaren Bay Region Hospital

Bay City, Michigan, 48708, United States

Location

Advanced Cardiac and Vascular Amputation Prevention Centers

Grandville, Michigan, 49418, United States

Location

Cardiac & Vascular Research Center of Nothern Michigan

Petoskey, Michigan, 49770, United States

Location

Cardiology Associates of North Mississippi

Tupelo, Mississippi, 38801, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

New York-Presbyterian / Columbia University Medical Center

New York, New York, 10032, United States

Location

North Caroline Hearth and Vascular- University of North Carolina Rex

Raleigh, North Carolina, 27607, United States

Location

The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinical Foundation

Cleveland, Ohio, 44195, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Greenville Health System

Greenville, South Carolina, 29615, United States

Location

North Dallas Research Associates

Dallas, Texas, 75069, United States

Location

Texas Tech

Lubbock, Texas, 79409, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Aurora Research Institute

Milwaukee, Wisconsin, 53233, United States

Location

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Universität Leipzig

Leipzig, 04203, Germany

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Tammy Stiver, Manager, Clinical Affairs
• Organization: Endologix

tstiver@endologix.com

5136731452

Study Officials

• Jihad Mustapha, MD

  Advanced Cardiac and Vascular Amputation Prevention Centers

  PRINCIPAL INVESTIGATOR

• Sean Lyden, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 18, 2017
• Study Start: December 13, 2017
• Primary Completion: December 22, 2021
• Study Completion: November 13, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); US (30); LA (1)