The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

The primary objective of the TORUS 2 IDE Clinical Study is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA or the superficial femoral and/or proximal popliteal arteries.

Key facts

Study ID: NCT04130737
Run by: Endologix
People needed: 188
Starts: 2018-08-13
Expected to finish: 2025-02-14
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
Patient provides written informed consent before any study-specific investigations or procedures.
Patient is willing to undergo all follow-up assessments according to the specified schedule over 36 months.
Patient is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
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.
Patient has PAD classified as Rutherford classification 2, 3 or 4.
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.
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.
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).
Target lesion(s) eligible for treatment under the protocol are at least least 3 cm above the bottom of the femur.
Target lesion(s) reference vessel diameter is between 5.0 mm and 6.7 mm by operator's visual estimate.
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).
Patient has a patent popliteal artery (no stenosis ≥ 50%) distal to the treated segment.
Patient has at least one patent infrapopliteal vessel (< 50% stenosis) with run-off to the ankle.

You may not qualify if…

Patient is unable or is unwilling to comply with the procedural requirements of the study protocol or will have difficulty in complying with the requirements for attending follow-up visits.
Patient has a comorbidity that in the investigator's opinion would limit life expectancy to less than 24 months.
Patient has any planned major surgical procedure (including any amputation of the target limb) within 30 days after the index procedure for this study.
Patient has a target vessel that has been treated with any type of surgical procedure prior to enrollment.
Patient has a target vessel that has been treated with bypass surgery.
Patient has PAD classified as Rutherford classification 0, 1, 5 or 6.
Patient has known or suspected active systemic infection at the time of enrollment.
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.
Patient has a stroke diagnosis within three months prior to enrollment.
Patient has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
Patient has a contraindication to antiplatelet, anticoagulant or thrombolytic therapies.
Patient has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-medicated.
Patient has known allergy to titanium, nickel or tantalum (does not include mild contact dermatitis due to nickel allergy).
Patient has received thrombolysis within 72 hours prior to the index procedure.
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.
Patient requiring coronary intervention within seven days prior to enrollment.
Patient is pregnant or breast-feeding.
Patient is participating in another research study involving an investigational product (pharmaceutical, biologic or medical device).
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.
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).
Patient has no patent (≥ 50% stenosis) outflow vessel providing run-off to the ankle.
There is a lack of full expansion in the predilatation balloon.
Evidence of aneurysm or acute thrombus in target vessel.

Where it is running

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

Full record on ClinicalTrials.gov

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