The PQ Bypass Pivotal IDE Intra-arterial Stent Graft Study for Occlusive and Re-stenotic Fem-pop Revascularization - 2 Trial: TORUS 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 188
- 试验地点
- 63
- 主要终点
- Freedom from a Major Adverse Event (MAE)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •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.
- •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.
研究组 & 干预措施
TORUS Stent Graft System
The TORUS Stent Graft System (SGS) is comprised of a Stent Graft (SG) and a Stent Graft Delivery System (SGDS).
干预措施: TORUS Stent Graft System (Device)
结局指标
主要结局
Freedom from a Major Adverse Event (MAE)
时间窗: 30 days
An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)
Primary Patency
时间窗: 12 months
Primary patency is defined as the absence of clinically-driven target lesion revascularization (CD-TLR) and absence of recurrent target lesion diameter stenosis \>50% by duplex ultrasound with a peak systolic velocity ratio of \>2.5.
Freedom From a Major Adverse Event (MAE)
时间窗: 30 days
An MAE is defined as all-cause death, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR)
次要结局
- Stent Fracture Rate(12 months)
- Adverse Event Rate(Through 36 months)
- Target Vessel Revascularization(Through 36 months)
- Change in Rutherford Clinical Classification(From procedure through 36 months)
- Major Adverse Event (MAE) Rate(12 months)
- Patency Rate(Through 36 months)
- Assisted Primary Patency Rate(Through 36 months)
- Walking Improvement Questionnaire (WIQ) Assessment(From procedure to 1, 6 and 12 months)
- Change in Toe Pressures(From procedure through 36 months)
- Change in Ankle-Brachial Index(From procedure through 36 months)
- Secondary Patency Rate(Through 36 months)
- Quality of Life Assessment by the EQ5D(From procedure to 1, 6 and 12 months)
- Technical Success(At the time of the index procedure)
- Procedural Success(Within 24 hours of the procedure)
- Alternative Patency Rate(Through 36 months)
- Patency Rate(Through 12 months)
- Clinically Driven Target Lesion Revascularization(Through 36 months)
- Major Amputation on Target Limb(Through 36 months)
- Change in Toe Pressures(Change from Baseline through 36 months)
- Walking Improvement Questionnaire (WIQ) Assessment(Change from baseline to 12-Month follow-up (Collected at 1M,6M, and 12M))
- Quality of Life Assessment by the EQ5D VAS(Change from baseline to 12-Month follow-up (Collected at 1M, 6M, and 12M))
- Change in Ankle-Brachial Index(Change from Baseline through 36 months)