Everolimus-Coated Percutaneous Transluminal Coronary Angioplasty Catheter First in Human Clinical Investigation: A Clinical Evaluation in the Treatment of Subjects With In-Stent Restenosis of Previously-treated Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 17
- 主要终点
- The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
研究概览
简要总结
The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.
详细描述
The CVT-ISR Trial is a prospective, multi-center, open, single arm study enrolling subjects with visually estimated nominal vessel diameter ≥2.0 mm and ≤3.5mm and lesion length ≤24 mm receiving up to two (2) CVT Everolimus CVT EVE-PTCA Catheters.
An angiographic follow up, in combination with either Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), follow-up, will be carried out in a subset of 25 patients at 180 days following the index procedure.
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 must be at least 18 years of age.
- •Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
- •Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, IVUS/OCT and examinations.
- •Angiographic Inclusion Criteria
- •Target lesion must be located within a stent (bare metal or drug eluting) placed in a native epicardial coronary vessel with visually estimated nominal vessel diameter of ≥2.0mm and ≤3.5mm.
- •Target lesion must measure ≤24 mm in length by visual estimation.
- •The target lesion must be with a visually estimated stenosis of ≥50% and < 100% with a TIMI flow of ≥
- •Non-clinical investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥90 days prior to or planned to be done 6 months after the index procedure.
- •Non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if planned to be done 6 months after the index procedure.
排除标准
- •Subject with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure and CK-MB or troponin have not returned within normal limits at the time of procedure.
- •The subject is currently experiencing clinical symptoms consistent with AMI.
- •Subject has current unstable arrhythmia.
- •Subject has a known left ventricular ejection fraction (LVEF) <25%.
- •Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine and structurally related compounds, everolimus, or contrast sensitivity that cannot be adequately pre-medicated.
- •Subject has known renal insufficiency (e.g., serum creatinine > 2.5 mg/dL, (i.e. 221 µmol/L) within 7 days prior to index procedure or creatinine clearance <30mL/min or subject is on dialysis.
- •Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- •Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months.
- •Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- •Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
- •Subject is not, in the opinion of the investigator, an acceptable candidate to participate in the study.
- •In-stent lesions for stent are located within an arterial or saphenous vein graft or stent used to treat a previous ISR.
- •The target vessel contains visible thrombus.
- •Pregnant or lactating females.
研究组 & 干预措施
Drug eluting balloon
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
干预措施: Drug Eluting Balloon (Device)
结局指标
主要结局
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
时间窗: 6 months post-index procedure
Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)
时间窗: 180 days post-procedure
In-Stent Late Lumen Loss (LLL) measures the reduction in the luminal diameter of a stented artery over a specified period after stent implantation, typically assessed using angiographic imaging. The unit of measurement for this outcome is expressed in millimeters (mm) or percentage (%), depending on the reporting method. The LLL is calculated by comparing the luminal diameter at a follow-up time point to the post-procedure luminal diameter.
次要结局
- Technical Success(12 months)
- Clinical Success (Per Subject)(12 months)
- Procedural Success(12 months)
- Rate of Vascular Access Site Complications(12 months)
- Clinically-driven Target Vessel Revascularization (TVR)(180 days and 12 months)
- Lesion Success:(12 months)
- Composite Rate of Target Lesion Failure (TLF)(30 days post-procedure and 12 months)
- Composite Rate of Target Vessel Failure (TVF)(30 days post-procedure, 180 days and 12 months)
- Clinically Driven Target Lesion Revascularization (TLR)(12 months)