The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study

Peripheral Arterial Disease, specifically in the superficial femoral arteries (SFA) and proximal popliteal arteries, are treated by a range of alternative practices and procedures for the patient population identified in the indications for use statement. Non-invasive approaches include exercise and drug therapy.

Minimally-invasive approaches include endovascular intervention using percutaneous transluminal angioplasty using a plain or drug-coated balloon, stents (bare metal, drug-eluting and covered) and various modalities of atherectomy.

SFA Stent Graft Systems have a clinical history that demonstrates that this device type is well understood, and the benefits and risks are well-characterized, i.e. mature technology.

Endologix believes that the clinical performance of the TORUS stent would be comparable to marketed SFA Stent Graft System. The TORUS 2 IDE Clinical Study will confirm this and is designed to demonstrate the safety and effectiveness of the TORUS Stent Graft System in patients with SFA and/or proximal popliteal artery disease

Inclusion criteria

• 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.

Exclusion criteria

• 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.