The DETOUR 2 Clinical Trial

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: PQ Bypass System

Registration Number: NCT03119233

Lead Sponsor: Endologix

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 202

Inclusion Criteria

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.
1. 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.
Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria
Stent within 3 cm of SFA ostium.
Previous bypass surgery on the target limb.
Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication)
Presence of aneurysm or acute thrombus in the target limb.
Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	PQ Bypass System	The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.

Primary Outcome Measures

Name	Time	Method
Primary Patency	12 months	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.
Major Adverse Events at 30 Days	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).

Secondary Outcome Measures

Name	Time	Method
Stent Graft Separation and Migration Via 12-Month X-Ray	12 Months	Stent graft separation and migration identified via X-ray
Stent Graft Separation and Migration	30 Days	Stent graft separation and migration identified via ultrasound imaging
Stent Graft Fracture Via 12-Month X-Ray	12-Months	Stent graft fracture identified via X-ray

Trial Locations

Locations (34): Universität Leipzig
🇩🇪
Leipzig, Germany
Pauls Stradins Clinical University Hospital
🇱🇻
Riga, Latvia
Christie Clinic
🇺🇸
Champaign, Illinois, United States
HonorHealth
🇺🇸
Scottsdale, Arizona, United States
The Vascular Experts
🇺🇸
Darien, Connecticut, United States
Baptist Hospital Miami
🇺🇸
Miami, Florida, United States
Advanced Cardiovascular Specialists
🇺🇸
Mountain View, California, United States
Bay Area Vein and Vascular
🇺🇸
Burlingame, California, United States
North Caroline Hearth and Vascular- University of North Carolina Rex
🇺🇸
Raleigh, North Carolina, United States
Cleveland Clinical Foundation
🇺🇸
Cleveland, Ohio, United States
The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education
🇺🇸
Cincinnati, Ohio, United States
Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
North Dallas Research Associates
🇺🇸
Dallas, Texas, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Texas Tech
🇺🇸
Lubbock, Texas, United States
Denver VA Medical Center
🇺🇸
Denver, Colorado, United States
Community Hospital of the Monterrey Peninsula
🇺🇸
Monterey, California, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, 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
New Mexico Heart Institute
🇺🇸
Albuquerque, New Mexico, United States
Cardiology Associates of North Mississippi
🇺🇸
Tupelo, Mississippi, United States
Aurora Research Institute
🇺🇸
Milwaukee, Wisconsin, United States
New York-Presbyterian / Columbia University Medical Center
🇺🇸
New York, New York, United States
Klinikum Hochsauerland GmbH
🇩🇪
Arnsberg, Germany
Cardioangiologisches Centrum Bethanien
🇩🇪
Frankfurt, Germany
St. Bernard's Medical Center
🇺🇸
Jonesboro, Arkansas, United States
First Coast Cardiovascular Institute
🇺🇸
Jacksonville, Florida, United States
Cardiac & Vascular Research Center of Nothern Michigan
🇺🇸
Petoskey, Michigan, United States
Greenville Health System
🇺🇸
Greenville, South Carolina, United States
Advanced Cardiac and Vascular Amputation Prevention Centers
🇺🇸
Grandville, Michigan, United States