Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
188 participants
INTERVENTIONAL
2019-10-31
2024-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TORUS Stent Graft System
The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS).
TORUS Stent Graft System
The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.
Interventions
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TORUS Stent Graft System
The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient provides written informed consent before any study-specific investigations or procedures.
3. Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
4. Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
5. Patient has symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion or restenosis of the native femoropopliteal artery.
6. Patient has PAD classified as Rutherford classification 2, 3 or 4.
7. Patient has documented PAD by either (i) a resting ankle-brachial index (ABI) of ≤ 0.90 (or ≤ 0.75 after exercise of the target limb). Resting toe brachial index (TBI) is performed only if unable to reliably assess ABI. TBI must be \<0.70; or (ii) Normal ABI with angiographic, ultrasound, MRA, or CT evidence of ≥ 60% diameter stenosis.
8. Patient has single or multiple stenotic, restenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
9. Single target lesion must be covered by a single stent. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and \> 30% diameter stenosis between the lesion(s).
10. Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
11. Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
12. Target lesion measures ≥ 80 mm to ≤ 180 mm in overall length, with ≥ 60% diameter stenosis by operator's visual estimate. Tandem target lesions are considered a single continuous lesion if the gap between lesions is ≤ 5 cm and \> 30% diameter stenosis between the lesion(s).
13. Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
14. Patient has at least one patent infrapopliteal vessel (\< 50% stenosis) with run-off to the ankle.
Exclusion Criteria
2. Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
3. Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
4. Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
5. Patient has a target vessel that has been treated with bypass surgery.
6. Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
7. Patient has known or suspected active systemic infection at the time of enrollment.
8. Patient has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR (international normalized ratio) \>1.8.
9. Patient has a stroke diagnosis within three months prior to enrollment.
10. Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
11. Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
12. Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
13. Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
14. Patient has received thrombolysis within 72 hours prior to the index procedure.
15. Patient has acute or chronic renal disease (e.g., as measured by a serum creatinine of \> 2.5 mg/dL or \> 220 μmol/L or GFR \< 30 ml/min), or on peritoneal or hemodialysis.
16. Patient requiring coronary intervention within seven days prior to enrollment.
17. Patient is pregnant or breast-feeding.
18. Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
19. Patient 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.
20. Patient 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).
21. Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
22. There is a lack of full expansion in the predilatation balloon.
23. Evidence of aneurysm or acute thrombus in target vessel.
18 Years
90 Years
ALL
No
Sponsors
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Syntactx
NETWORK
PQ Bypass, Inc.
INDUSTRY
Endologix
INDUSTRY
Responsible Party
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Locations
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Southwest CVA
Mesa, Arizona, United States
Vascular Heart & Lung Associates
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Yuma Cardiology Associates
Yuma, Arizona, United States
Arkansas Heart
Little Rock, Arkansas, United States
Bay Area Vein & Vascular Institute
Burlingame, California, United States
UCSF
San Francisco, California, United States
Rocky Mountain Regional VAMC
Aurora, Colorado, United States
The Vascular Experts
Darien, Connecticut, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Palm Vascular Centers
Miami Beach, Florida, United States
Coastal Vascular & Interventional
Pensacola, Florida, United States
Florida Cardiology
Winter Park, Florida, United States
AMITA Health
Elk Grove, Illinois, United States
MedStar Health Research Insitute
Hyattsville, Maryland, United States
McLaren Bay Region
Bay City, Michigan, United States
Michigan Vascular Center
Flint, Michigan, United States
Eastlake Cardiovascular
Roseville, Michigan, United States
Northern Mississippi Medical Center
Tupelo, Mississippi, United States
Columbia University Medical Center
New York, New York, United States
Novant Health
Charlotte, North Carolina, United States
NC Heart & Vascular Research
Raleigh, North Carolina, United States
The Lindner Center for Research & Education
Cincinnati, Ohio, United States
Naadi
Oklahoma City, Oklahoma, United States
The Miriam Hospital
Providence, Rhode Island, United States
Prisma Health
Greenville, South Carolina, United States
North Central Heart
Sioux Falls, South Dakota, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Texas Tech
Lubbock, Texas, United States
North Dallas Research Associates
McKinney, Texas, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Bellin Hospital
Green Bay, Wisconsin, United States
Countries
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Other Identifiers
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CLN 227
Identifier Type: -
Identifier Source: org_study_id
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