JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 26
- 主要终点
- Percentage of Participants With Target Lesion Revascularization (TLR)
研究概览
简要总结
The purpose of this study is to test the hypothesis that Jetstream atherectomy (JS) and adjunctive balloon angioplasty (PTA) (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from PTA alone in the treatment of femoropopliteal (FP) arterial In-stent restenotic (ISR) disease.
This is a prospective, multicenter, single arm study evaluating the investigational use of Jetstream Atherectomy (JS) and adjunctive balloon angioplasty (JS +PTA) in the treatment of FP ISR lesions in subjects with claudication or limb ischemia (Rutherford clinical category (RCC) of 2-4) (lesion length ≥ 4 cm). The comparator arm is historic data from plain old balloon angioplasty derived from a Meta-analysis of the 3 published randomized trials in the field.
详细描述
The Boston Scientific Jetstream XC catheter is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. The JS XC System has been cleared by the Food and Drug Administration (FDA) for use in the peripheral vasculature to treat denovo and non-stent infrainguinal lesions
Several studies have shown that stenting of the FP artery leads to higher long term patency. Bare metal stents however have not shown conclusively to reducemTLR which is in contrast to drug coated balloons (DCB) and drug coated stents (DCS). Irrespective, stenting has several disadvantages including a continued high rate of restenosis and stent fractures that is progressive with time. FP ISR occurs in more than one third of patients at 1 year and up to 49% at 2 years. Complex lesions (long, Trans-Atlantic Inter-Society Consensus II C/D lesions, total occlusions), certain demographics (female gender, diabetes mellitus), critical limb ischemia and significant stent fractures are associated with a higher rate of restenosis. Also the majority of occluded stents are restenotic-thrombotic and generally are more challenging to treat.
Recently 3 randomized trials were presented in treating FP ISR; the EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) trial (randomized laser + PTA vs PTA alone), the RELINE trial (Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery) and the Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. All these studies showed superiority over PTA in treating FP ISR. Early animal data (porcine model of FP ISR) and feasibility human data (JetStream ISR study) have shown that the JetStream device is effective in ablating restenotic tissue within restenotic FP stents and had no safety concerns within well apposed stents and in the absence of Class III and IV fractures.
The purpose of this study is to assess and estimate the effect of treating FP ISR with plaque excision using JS in combination with adjunctive PTA and compare this to historic control of PTA. The comparator arm is historic data from PTA derived from a study-level meta-analysis of the 3 published randomized trials in the field.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)
- •Previously treated with stenting in the femoropopliteal segment
- •No limit on how many times the target in-stent restenotic lesion has been previously treated.
- •There is no exclusion based on how the prior treatment was done including if drug eluting balloons or stents have been used. Covered stents cannot be included
- •There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled
排除标准
- •Subjects must meet all of the following criteria to be eligible to participate in this study:
- •Subject is 18 years of age or older.
- •Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
- •Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb pain or claudication.
- •Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
- •The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
- •The main target vessel reference diameter must be > or = 5 mm and ≤ 7 mm
- •One patent distal run-off vessel with <70% disease and with brisk flow is required.
- •Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion
- •Patient has signed approved informed consent.
- •Patient is willing to comply with the follow-up evaluations at specified times.
结局指标
主要结局
Percentage of Participants With Target Lesion Revascularization (TLR)
时间窗: 6 months
TLR is defined as retreatment of the index lesion (extended 1 cm proximal and distal to the lesion) at 6 months. For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered meeting a TLR endpoint. (ITT analysis)
Major Adverse Events (MAE)
时间窗: 30 days
unplanned major amputation, all cause mortality, and Bailout Stenting consider Target Lesion Revascularization (TLR).
次要结局
- Device Outcome(Intraprocedural)
- Procedural Success(Intraprocedural)
- Target Lesion Revascularization (TLR) With no Bailout Stent Included(6 months)
- Ankle Brachial Index(1 Year)
- Clinically Driven Target Lesion Revascularization(12 months)
- Target Lesion Revascularization (TLR)(1 year)
- Clinical Patency(1 year)
- Change in Walking Impairment Questionnaire Score(Baseline and 6 months)
- Number of Participants With Rutherford Clinical Category Improvement(6 months)
- Change in Ankle-Brachial Index(6 months)
- Change in Walking Impairment Questionnaire at 1 Year(1 Year)
- Rutherford Clinical Category(1 Year)