Study Results
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View full resultsBasic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2017-12-13
2023-11-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-Arm
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)
DETOUR System
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).
Interventions
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DETOUR System
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).
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
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.
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.
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.
18 Years
90 Years
ALL
No
Sponsors
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Endologix
INDUSTRY
Responsible Party
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Principal Investigators
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Jihad Mustapha, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Cardiac and Vascular Amputation Prevention Centers
Sean Lyden, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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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
Greenville Health System
Greenville, South Carolina, United States
North Dallas Research Associates
Dallas, Texas, United States
Texas Tech
Lubbock, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Aurora Research Institute
Milwaukee, Wisconsin, United States
Klinikum Hochsauerland GmbH
Arnsberg, , Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Universität Leipzig
Leipzig, , Germany
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STP 203
Identifier Type: -
Identifier Source: org_study_id
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