Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Target Lesion Percent Stenosis
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation
详细描述
This is a prospective, two-arm randomized study. The control cohort (PTX PTA group, Admiral Inpact or Pacific Inpact, Medtronic-Invatec) will be treated with a PTX-coated PTA balloon. The experimental cohort (Laser+PTX PTA group) will be treated with photoablative atherectomy followed by a PTX-coated PTA balloon. Subjects meeting the definitions of Rutherford Clinical Categories 1 to 5 with instent lesions located in superficial femoral artery and the popliteal artery above the knee joint are eligible for enrollment.
The purpose of this feasibility study is to evaluate the safety and effectiveness of preparing an instent lesion with photoablative atherectomy prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablative atherectomy.
Primary Outcome:
Target Lesion Percent Diameter Stenosis (%DS) at 1 Year defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the ACL.
Secondary Outcomes:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must meet all of the following general inclusion criteria.
- •Has a Rutherford Clinical Category Score of 1 -
- •Is willing and capable of complying with all follow-up evaluations at the specified times.
- •Is ≥ 18 years old.
- •Provides written informed consent prior to study specific procedures.
排除标准
- •The subject must not meet any of the following general exclusion criteria.
- •Has contraindications listed in any study device IFUs.
- •Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
- •Has a hypersensitivity to contrast material that cannot be adequately pretreated.
- •Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
- •Has life expectancy of less than 12 months.
- •Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.
- •Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
- •Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
- •Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.
- •Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
- •Has had a previous peripheral bypass affecting the target vessel.
- •Has chronic renal insufficiency with creatinine > 2.5 mg/L (except patients under chronic renal replacement therapy).
- •Is unable or unwilling to receive dual anti-platelet therapy.
- •Equipment is unavailable to fulfill study treatments.
结局指标
主要结局
Target Lesion Percent Stenosis
时间窗: at 1 Year
Target Lesion Percent Stenosis at 1 Year: Defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the angiographic core lab.
次要结局
- Procedural Success(at 1 year)