NCT04241224已完成不适用
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
Ra Medical Systems19 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年2月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 19
- 主要终点
- Technical Success
研究概览
简要总结
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the inclusion criteria to participate in this study:
- •Inclusion Criteria
- •Ability and willingness to give written informed consent and comply with follow-up requirements
- •PAD with Rutherford Class 2-5
- •Stenotic lesion(s) in the peripheral vasculature
- •Subject is a candidate for atherectomy for infrainguinal peripheral artery disease
- •Angiographic Inclusion Criteria
- •Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
- •Target vessel ≤ 3.0 mm in diameter
- •Target Lesion ≤ 25cm in length
- •The lesion to be treated is not severely calcified
- •Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
- •No use of another atherectomy device in the same procedure
- •Treatment site is not located in a graft
- •Treatment site is not in, or distal to, a previously placed stent
- •No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device)
- •Participants meeting any of the
排除标准
- •at the time of enrollment (index procedure/ intervention) will be excluded from study participation:
- •Exclusion Criteria
- •Age below 22 years
- •Pregnant, breastfeeding, planning to become pregnant. If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
- •Myocardial infarction (MI) ≤ 60 days prior to procedure
- •Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
- •Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
- •Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
- •Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
- •Life expectancy ≤ 12 months
- •Patient is participating in another investigational drug or device study
结局指标
主要结局
Technical Success
时间窗: At Index Procedure
The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory.
Freedom from Major Adverse Events (MAE)
时间窗: 30 Days
Primary safety endpoint is freedom from Major Adverse Events, defined as all-cause mortality, unplanned major target limb amputation (at or above the ankle), clinically driven target limb revascularization (CD-TLR) at 30 Days, as classified by the Clinical Events Committee (CEC).
次要结局
- Incidence of Target Lesion Revascularization (TLR) at 6 months(6 months)
- Vessel Patency(30 Days, 6 Months)
- Reduction in Residual Diameter Stenosis(At Index Procedure)
- Rutherford Classification(30 Days, 6 Months)
- Change in Percent Diameter Stenosis(30 Days, 6 Months)
研究者
研究点 (19)
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