A Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCAÂ® in Treatment of Patients with Single or Multivessel Coronary Artery Disease (CAD) - ELCA Study

Spectranetics Corporation0 个研究点目标入组 28 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•The subjects have to meet the following inclusion criteria:
•1. Patient 18 years to 75 years, both inclusive
•2. Have at least one severe stenotic lesion (greater than or equal to 80% diameter stenosis as assessed by visual estimation)
•3. 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.
•4. Angiographic evidence of calcification or a chronic total occlusion
•5. Vessel reference diameter greater than or equal to 2.0 mm
•6. Patient is willing and able to comply with study requirements
•7. Women of child bearing potential , willing to use at least two methods of contraception.

•The subjects do not meet any of the following exclusion criteria:
•1. Evidence of acute coronary syndrome within 3 months prior to index procedure
•2. Evidence of acute ischemic events
•3. Cardiogenic and non-cardiogenic shock
•4. Active bleeding or coagulopathy
•5. Previous coronary angioplasty within 6 months of the index procedure
•6. Patients participating in trial for another investigational device/medicine within 1 month prior to enrolment in this study
•7. 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
•8. 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
•9. Planned surgery within 6 months of enrollment in this study
•10. Life expectancy less than 6 months
•11. Patients known to be suffering from substance abuse (alcohol or drug)
•12. Patients with any other significant co-morbid illness which in the opinion of the investigator is not conducive of inclusion in the study.
•13. Known or suspected Pregnancy
•14. Patients not willing to provide written informed consent
•15. In the investigators opinion subjects will not be able to comply with the follow-up requirements.

发起方

Spectranetics Corporation