Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Ankle-Brachial Index (ABI) Measurments
研究概览
简要总结
IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).
详细描述
This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months.
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
- •Subject's age ≥ 18 years
- •Subject is an acceptable candidate for percutaneous intervention using the Sponsor's OAS in accordance with its labeled indications and instructions for use
- •Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or tibioperoneal trunk (TPT)
- •Tight lesions (>70% stenosis)
- •Lesions less than 110 mm in length
- •Artery with the vessel < 6.5 mm in diameter
- •Subject is willing and able to sign an approved informed consent form
- •Subject is willing and able to attend follow-up visits
排除标准
- •Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to contrast agent
- •Unable to take appropriate antiplatelet therapy
- •Subject has no distal run-off
- •Interventional treatment is intended for in-stent restenosis at the peripheral vascular site
- •Subject has history of coagulopathy or hypercoagulable disorder, is undergoing hemodialysis or has impaired renal function (Cr > 2.5 mg/dl) at the time of treatment
- •Female subject who is pregnant or nursing a child
- •Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Sponsor's OAS
结局指标
主要结局
Ankle-Brachial Index (ABI) Measurments
时间窗: Baseline, 2 weeks, 6 months and 12 months
The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.
Rutherford Classification (RC)
时间窗: Baseline, 2 weeks, 6 month and 12 month
Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit. RC classification is as follows: RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable
Stent Usage at the Time of the Index Procedure
时间窗: Index Procedure
Number of lesions with a stent placed during the index procedure.
Rate of Clinically Driven Target Lesion Revascularization (TLR)
时间窗: 6 months and 12 months
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.
Mean Maximum Balloon Inflation Pressure
时间窗: Index Procedure
Mean maximum balloon inflation pressure of balloons used pre-stent placement.
Rate of Procedural Angiographic Complications
时间窗: Index Procedure
Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).
Percent (%) Area Stenosis
时间窗: Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)
Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).
次要结局
未报告次要终点