A Prospective, Multicenter, Open Label Randomized Study to Evaluate the Safety, Performance and Intraluminal Crossing of the TruePath™ CTO Device Versus The Crosser System in Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Technical Success
研究概览
简要总结
This is a prospective, multicenter, randomized, single-blind study enrolling up to 75 subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per hospital protocol and antiplatelet therapy with aspirin and clopidogrel.
详细描述
The primary objective of the study is to compare the technical success and in-hospital safety of TruePath device with that of the CROSSER device in patients with symptomatic femoro-popliteal CTO. Subjects will be followed clinically while in the hospital and at 1 month following the index procedure. All subjects will undergo procedural intravascular ultrasound (IVUS) imaging. The study population will consist of up to 75 patients with symptomatic femoro-popliteal CTO and indications for revascularization. Subjects must have a previously documented conventional percutaneous procedure or a concurrent failed attempt to cross the CTO using conventional guidewire techniques. All subjects must meet all inclusion and no exclusion criteria and sign an Informed Consent Form approved by the local Institutional Review Board (IRB) prior to enrollment and randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Inclusion Criteria
- •Male or non-pregnant female ≥18 years of age;
- •Rutherford Clinical Category 2-5
- •Patients is willing to provide informed consent and comply with the required follow-up visits, testing schedule, and medication regimen
- •Angiographic Lesion Inclusion Criteria
- •Length ≤35 cm
- •The lesion is a single lesion or composite of multiple lesions within the 35 cm segment
- •100% stenosis by visual estimate
- •Previously documented conventional percutaneous procedure or a concurrent failed attempt to cross the CTO using conventional guidewire techniques
- •Ability to visualize target artery distal to the lesion (via collateral circulation)
- •Target lesion located in the superficial femoral/proximal popliteal arteries, with lesion location starting ≥1cm below the common femoral bifurcation
- •De novo lesion or restenotic lesion >30 days from any prior endovascular intervention
- •Target vessel diameter ≥4 and ≤7 mm and able to be treated with PTA and or a stent
- •A patent inflow artery free from significant lesions (≥50% stenosis) as confirmed by angiography. Treatment of the target lesion may be performed after successful treatment of existing inflow artery lesions at the time of the index procedure. [NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤50% without death or major vascular complication.]
- •At least one patent outflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is permitted)
排除标准
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 months following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done prior to the index procedure.
- •Rutherford Class 0, 1 or 6
- •History of hemorrhagic stroke within 3 months
- •Renal failure or chronic kidney disease with MDRD GFR ≤ 30 ml/min per 1.73m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis)
- •Previous or planned surgical or interventional procedure to the target limb within 2 weeks before (aside from conventional percutaneous procedure during the current hospitalization) or within 30 days after the index procedure
- •Prior vascular surgery of the index limb, with the exception of common femoral patch angioplasty remote from the target lesion
- •Planned use of adjunctive primary treatment modalities (e.g., laser, atherectomy, cryoplasty, scoring/cutting balloon, or other)
- •Inability to take required study medications or an allergy to contrast that cannot be controlled with medication
- •Life expectancy of <1 years
- •Patient is currently participating in an investigational drug or device study or previously enrolled in this study Subject enrollment and treatment
研究组 & 干预措施
TruePath CTO Device
The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018" guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
干预措施: TruePath CTO Device (Device)
CROSSER CTO Device
The CrosserTM CTO Recanalization Catheter ("Crosser system") (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.
干预措施: CROSSER CTO Device (Device)
结局指标
主要结局
Technical Success
时间窗: Day of operation
Technical success, defined as the ability to facilitate complete intraluminal crossing of a CTO into the true distal lumen with a TruePath or a CROSSER device and/or any subsequent conventional guidewire, as confirmed by IVUS imaging
In-hospital Safety
时间窗: Operation through 30 day follow up
In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR)
次要结局
- Procedural Success(Day of operation)
- Clinical Success(Day of operation)
- Symptomatic Improvement(Baseline, and 30 days post operation)
- Walking Capacity(Baseline and 30 days post operation)
- Index Limb Amputation(Day of Operation through 30 days post operation)
- Target Lesion Revascularization(30 days post operation)
- Ankle-brachial Index (ABI)(baseline to 30 days post operation)
- Target Vessel Revascularization(30 days post operation)
- Angiographic Perforation Classification and Rate(Day of operation)