Clinical trial NCT03119233: The DETOUR 2 Clinical Trial
Official title: The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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.

   Clinical Inclusion Criteria
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.

   Angiographic Inclusion Criteria
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.
11. At least one patent infrapopliteal vessel (\<50% stenosis) with run-off to the ankle or foot.
12. 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

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.

   Clinical Exclusion Criteria
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.
11. Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.
12. Morbid obesity that does not allow for safe vascular access or imaging.
13. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR \> 1.8.
14. Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion.
15. Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.
16. Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria
17. Stent within 3 cm of SFA ostium.
18. Previous bypass surgery on the target limb.
19. 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)
20. Presence of aneurysm or acute thrombus in the target limb.
21. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

Primary outcomes:
measure: Primary Patency
timeFrame: 12 months
measure: Major Adverse Events at 30 Days
timeFrame: 30 days
Secondary outcomes:
measure: Stent Graft Separation and Migration
timeFrame: 30 Days
measure: Stent Graft Separation and Migration Via 12-Month X-Ray
timeFrame: 12 Months
measure: Stent Graft Fracture Via 12-Month X-Ray
timeFrame: 12-Months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Burlingame
country: United States
facility: Bay Area Vein and Vascular
state: California
city: Monterey
country: United States
facility: Community Hospital of the Monterrey Peninsula
state: California
city: Mountain View
country: United States
facility: Advanced Cardiovascular Specialists
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Miami
country: United States
facility: Baptist Hospital Miami
state: Florida
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Elk Grove Village
country: United States
facility: AMITA Health Alexian Brothers Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay Region Hospital
state: Michigan
city: Grandville
country: United States
facility: Advanced Cardiac and Vascular Amputation Prevention Centers
state: Michigan
city: Petoskey
country: United States
facility: Cardiac & Vascular Research Center of Nothern Michigan
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: New York-Presbyterian / Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: North Caroline Hearth and Vascular- University of North Carolina Rex
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital - The Carl & Edyth Lindner Center for Research & Education
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinical Foundation
state: Ohio
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Dallas
country: United States
facility: North Dallas Research Associates
state: Texas
city: Lubbock
country: United States
facility: Texas Tech
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Research Institute
state: Wisconsin
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland GmbH
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
Study officials:
affiliation: Advanced Cardiac and Vascular Amputation Prevention Centers
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Sean Lyden, MD
role: PRINCIPAL_INVESTIGATOR
References: