A Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or Multivessel Coronary Artery Disease (CAD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Device Success: Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
研究概览
简要总结
This is a Prospective, Open label, Non-randomized,Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy ofELCA® in Treatment of Patients with Single or Multivessel Coronary ArteryDisease (CAD).
A total of 30 patients with Single or Multi vessel CoronaryArtery Disease (CAD) will be enrolled at up to 5 investigational sites inIndia.
Each subject will be followed from enrollment through 30 days± 7 days for the effectiveness and safety endpoints.
The primary endpoints are :
· Device Success: Successful crossing of the Laser Catheter across theentire length of the stenotic lesion
· Procedural Success: Target lesions with less than 50% residualstenosis after laser and adjunctive therapy
SafetyEndpoints are :
· Freedom from Major Adverse Cardiac Events (MACE) through hospitaldischarge and at one month.
MACEis defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), TargetLesion Revascularization, Cardiac Tamponade and Life-threatening arrhythmias
· TIMI Flow
· Lesion Morphology
· Device-related complications
· Procedure-related complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects have to meet the following inclusion criteria:
- •Patient 18 years to 75 years, both inclusive
- •Have at least one severe stenotic lesion (greater than or equal to 80% diameter stenosis as assessed by visual estimation)
- •Hemodynamically stable patients coming to the site for cardiac catheterization and angiography who fulfill all the following criteria: 3.1 Have no clinically significant cardiac arrhythmias, based on ECG results 3.2 Have no evidence of valvular pathology, based on echocardiogram results 3.3 Have ≥30% left ventricular ejection fraction (LVEF), based on echocardiogram results.
- •Angiographic evidence of calcification or a chronic total occlusion
- •Vessel reference diameter greater than or equal to 2.0 mm
- •Patient is willing and able to comply with study requirements
- •Women of child bearing potential , willing to use at least two methods of contraception.
排除标准
- •The subjects do not meet any of the following exclusion criteria:
- •Evidence of acute coronary syndrome within 3 months prior to index procedure
- •Evidence of acute ischemic events
- •Cardiogenic and non-cardiogenic shock
- •Active bleeding or coagulopathy
- •Previous coronary angioplasty within 6 months of the index procedure
- •Patients participating in trial for another investigational device/medicine within 1 month prior to enrolment in this study
- •Acute or Chronic renal failure, Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l) determined within 72 hours prior to index procedure
- •Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin, Sirolimus or its derivatives, contrast agent (that cannot be adequately pre-medicated), or any metal
- •Planned surgery within 6 months of enrollment in this study
- •Life expectancy less than 6 months
- •Patients with any other significant co-morbid illness which in the opinion of the investigator is not conducive of inclusion in the study.
- •Known or suspected Pregnancy
- •Patients not willing to provide written informed consent
- •In the investigators opinion subjects will not be able to comply with the follow-up requirements.
结局指标
主要结局
Device Success: Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
时间窗: NA
次要结局
- Freedom from Major Adverse Cardiac Events (MACE) through hospital discharge and at one month.(MACE is defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life-threatening arrhythmias)
- TIMI Flow(1 month post procedure)
- Lesion Morphology(1 month post procedure)
- Device-related complications(NA)
- Procedure-related complications(NA)