A clinical study to evaluate the procedural safety and efficacy of ELCAÂ® in treatment of patients with Single or Multivessel Coronary Artery Disease (CAD).

Phase 3

Completed

Conditions: Patients with Single or Multivessel Coronary Artery Disease (CAD)

Brief Summary: This is a Prospective, Open label, Non-randomized,Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy ofELCAÂ® 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 daysÂ± 7 days for the effectiveness and safety endpoints.

The primary endpoints are :

Â·        Device Success: Successful crossing of the Laser Catheter across theentire length of the stenotic lesion

Â·        Procedural Success: Target lesions with less than 50% residualstenosis after laser and adjunctive therapy

SafetyEndpoints are :

Â·        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

Â·        TIMI Flow

Â·        Lesion Morphology

Â·        Device-related complications

Â·        Procedure-related complications

Recruitment & Eligibility

Inclusion Criteria

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 â‰¥30% left ventricular ejection fraction (LVEF), based on echocardiogram results.
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.

Exclusion Criteria

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 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 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.

Primary Outcome Measures

Name	Time	Method
Device Success: Successful crossing of the Laser Catheter across the entire length of the stenotic lesion	NA

Secondary Outcome Measures

Name	Time	Method
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

Locations (5): All India Institute of Medical Sciences (AIIMS)
🇮🇳
Delhi, DELHI, India
Escorts Heart Institute & Research Centre
🇮🇳
Delhi, DELHI, India
Lilavati Hospital & Research Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Medanta â€“ The Medicity
🇮🇳
Gurgaon, HARYANA, India
Sri Jayadeva Institute of Cardiology
🇮🇳
Bangalore, KARNATAKA, India
All India Institute of Medical Sciences (AIIMS)
🇮🇳Delhi, DELHI, India
Dr Vinay Kumar Bahl
Principal investigator
919871053131
vkbahl2002@yahoo.com