The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study

The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2

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.

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:

1. Patient is male or female, with age > 18 and ≤ 90 years at date of enrollment.
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:

1. 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.
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.