Atherectomy By Laser Ablation With Turbo-Elite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
研究概览
简要总结
The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.
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
- •PAD with Rutherford Class 1-4
- •Patient is able to walk unassisted or with non-motorized assistive devices.
- •Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
- •Documented stenosis by duplex ≥50%
排除标准
- •Patient is pregnant or breast feeding.
- •Evidence of Acute Limb Ischemia within 7 days prior to procedure.
- •CVA < 60 days prior to procedure.
- •MI < 60 days prior to procedure.
- •Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
- •Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- •Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
- •Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
- •Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
- •Previously identified severe calcium in the vessel.
结局指标
主要结局
Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
时间窗: Day 1
The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint.
Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)
时间窗: 30 day follow-up
The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization.
次要结局
- Freedom From Target Lesion Revascularization (TLR) Through 180 Days.(Day 180 (6 Months))
- Final Procedure Residual Stenosis After All Therapy(Day 1)
- Rutherford Class (RCC) Change(Baseline and 30 days of procedure)
- Characterization of Adjunctive Therapy Use(Day 1)
- Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.(Baseline and 30 Days post-procedure)