Complete Lesion Assessment With ffR and IVUS TechnologY (CLARITY I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 16
- 主要终点
- Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
研究概览
简要总结
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
详细描述
This prospective, randomized, multi-center, post-market study of approximately 50 subjects randomized 1:1 to Orbital Atherectomy (OA) performed with Cardiovascular Systems, Inc.'s Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) vs. BA alone for treatment of tibial vessel disease, defined as ≥ 50 % stenosis of the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT), or peroneal (PR) arteries by angiography. All subjects will have a corresponding wound being fed by the target vessel which will be assessed during the study. Subjects will be followed to one year.
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's age ≥ 18 years.
- •Subject is an acceptable candidate for percutaneous intervention with the Sponsor's OAS and BA in accordance with their labeled indications and instructions for use.
- •Subject is willing and able to sign an approved informed consent form (ICF).
- •Subject is willing and able to attend follow-up and wound care visits.
排除标准
- •Subject is pregnant or planning to become pregnant within the study period.
- •Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this trial.
- •Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated.
- •Uncontrolled allergy to nitinol, stainless steel, or other stent materials.
- •Subject has known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide.
- •Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Subject has been diagnosed with chronic renal failure or has a creatinine level > 2.5, unless on dialysis, prior to the index treatment.
- •Subject has evidence of intracranial or gastrointestinal bleeding within 90 days.
- •Subject has a history of trauma, fracture, major surgery (includes major amputation), or biopsy of a parenchymal organ within past 14 days, or patient has not healed from a previous medical intervention occurring more than 14 days.
- •Subject has a history of stroke or myocardial infarction (MI) within 90 days prior to enrollment in the study.
- •Subject has a planned major surgery (includes major amputation) scheduled within 60 days after treatment of the index limb.
- •Subject has a planned interventional treatment to address stenosis of the contralateral limb scheduled within 60 days after the index treatment.
- •Subject has a planned interventional treatment to address inflow stenosis of the ipsilateral limb scheduled within 60 days after the index treatment.
- •Inflow or bilateral PAD requiring treatment prior to enrollment was not successfully treated, defined as > 50% residual stenosis and/or occurrence of procedural angiographic complications, excluding dissection types A and B.
- •Subject has previously had their other limb treated as part of the study.
- •Angiographic Inclusion Criteria:
- •Target lesion(s) located in the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT) or peroneal (PR) arteries.
- •Target lesion has ≥ 50 % stenosis by angiography.
- •Subject has a corresponding wound being fed by the target vessel.
- •Angiographic Exclusion Criteria:
- •Target limb does not have any visual flow to the foot confirmed via distal selective angiography.
- •Thrombus is present or suspected in the target treatment vessel.
- •Target lesion is within a bypass graft or near a previously placed stent.
- •The guide wire cannot be passed across the target lesion.
- •Anterograde access of the lesion is not possible.
- •Subject has angiographic evidence of significant dissection at or near the treatment site.
- •Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
- •Subject's wound(s) involve multiple angiosomes.
结局指标
主要结局
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
时间窗: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.
Change in Plaque Area as Assessed by IVUS
时间窗: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.
Change in Dense Calcium Area as Assessed by IVUS
时间窗: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.
Change in Necrotic Core Area as Assessed by IVUS
时间窗: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.
Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS
时间窗: Post-balloon angioplasty
The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.
Change in Fibrous Plaque Area as Assessed by IVUS
时间窗: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.
Change in Fibrofatty Plaque Area as Assessed by IVUS
时间窗: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrofatty plaque area. A positive value equates to a decrease in fibrofatty plaque area.
次要结局
- Fractional Flow Reserve(Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms))