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
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 9
- 主要终点
- Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
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 of ELCA® in Treatment of Patients with Single or Multivessel Coronary Artery Disease (CAD). Up to 30 patients will be enrolled at up to 05 Indian study sites. Patients will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints at the study centre.
详细描述
Each subject will be followed from enrollment through 30 days ± 7 days for the effectiveness and safety endpoints. Upon enrollment after obtaining a written informed consent, each patient will be assigned a unique identification number. Only patients eligible to undergo cardiac catheterizations as per routine practice will be considered for the study. Premedication of patients will be as per the investigator's routine practice. All patient data will be recorded on patient data forms.
Screening: This will be performed prior to the cardiac catheterization procedure. Only patients who have consented and fulfill the selection criteria will be enrolled. Additionally, ECG and Echocardiogram will be done using hospital equipment to ensure fulfillment of inclusion/exclusion criteria.
Procedure: The entire procedure will be carried out as per the site routine practice and the device will be used as per the IFU.
Clinic follow up visit (30 ± 7 days): The subject will return to the clinic at 1 month to evaluate angina status as per the CCS classification, AE assessments, concomitant medications and any coronary intervention that has occurred since the previous contact.
An electrocardiogram (ECG) will be repeated during the clinic visit.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least one severely stenotic lesion (greater than or equal to 80% diameter stenosis as assessed by visual estimation)
- •Haemodynamically stable patients coming to the site for cardiac catheterization and angiography for various indications and who fulfill all the following criteria:
- •Have no clinically significant cardiac arrhythmias, based on ECG results
- •Have no evidence of valvular pathology, based on echocardiogram results
- •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
- •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 umol/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 known to be suffering from substance abuse (alcohol or drug)
- •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
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
时间窗: Procedure
Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
时间窗: Procedure
Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
Safety Success - Participants With Freedom From Major Adverse Cardiac Events (MACE) Defined as Death, Non-Q-wave and Q-wave Myocardial Infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life Threatening Arrhythmias
时间窗: 30 days
Freedom from Major Adverse Cardiac Events (MACE) defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac tamponade and life threatening arrhythmias.
次要结局
- Participants With Device-related Complications During Procedure(Procedure)
- Lesion Morphology - Bifurcation (Branch or Division of Artery)(Procedure)
- Participants With Procedure-related Complications During Procedure(Procedure)
- Lesion Morphology - Contour as a Lesion Characteristic(Procedure)
- TIMI Flow(pre-procedure and post-procedure)
- Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity(Procedure)
- Lesion Morphology - Eccentricity of Coronary Lesion(Procedure)