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CTRI Number  CTRI/2017/09/009768 [Registered on: 14/09/2017] Trial Registered Prospectively
Last Modified On: 19/07/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the procedural safety and efficacy of ELCA® in treatment of patients with Single or Multivessel Coronary Artery Disease (CAD). 
Scientific Title of Study   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) 
Trial Acronym  ELCA Study 
Secondary IDs if Any  
Secondary ID  Identifier 
ELCA-1016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Bina Naik 
Designation  Director 
Affiliation  CBCC-Vibgyor Research Pvt. Ltd. 
Address  Second floor, Skoda house, Opp. LJ campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  9726434201  
Fax  9726434204  
Email  elca@vibgyorcare.com  
 
Details of Contact Person
Public Query  
Name  Mr Srinivas Maddali 
Designation  Director, South & Southeast Asia 
Affiliation  Spectranetics Corporation 
Address  3132, Sobha Petunia, Nagawara ORR, Hebbal, Bangalore 560045 INDIA

Bangalore
KARNATAKA
560045
India 
Phone  919880562211  
Fax    
Email  srinivas.maddali@spnc.com  
 
Source of Monetary or Material Support  
Spectranetics Corporation, Colorado, US 
 
Primary Sponsor  
Name  Spectranetics Corporation 
Address  9965, Federal Drive, Colorado Springs, CO 80921, US 
Type of Sponsor  Other [Medical Devices-International] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinay Kumar Bahl  All India Institute of Medical Sciences (AIIMS)  Ansari Nagar, New Delhi -110029, India
New Delhi
DELHI 		 919871053131

vkbahl2002@yahoo.com 
Dr Ashok Seth  Escorts Heart Institute & Research Centre  Okhla Road, New Delhi -110025, India
New Delhi
DELHI 		 911126825001

ashok.seth@fortishealthcare.com 
Dr Samuel Mathew Kalarickal  Lilavati Hospital & Research Centre  A-791, Bandra Reclamation, Bandra (W), Mumbai - 400050. India
Mumbai
MAHARASHTRA 		 919841071118

drmathew.sk@gmail.com 
Dr Praveen Chandra  Medanta – The Medicity  Sector 38, Gurgaon, Haryana 122018, India
Gurgaon
HARYANA 		 919810125370

praveen.chandra@medanta.org 
Dr C N Manjunath  Sri Jayadeva Institute of Cardiology  Jayanagara 9th Block, Bannerghatta main road, Bengaluru, Karnataka 560069, India
Bangalore
KARNATAKA 		 919844006699

drcnmanjunath@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, Lilavati Hospital and Research Centre  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Fortis Escorts Heart Institute  Approved 
Medanta Institutional Ethics Committee  Approved 
Sri Jayadeva Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with Single or Multivessel Coronary Artery Disease (CAD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Excimer Laser Coronary Atherectomy (ELCA®)  ELCA® products are approved by FDA (US) and CE mark (EU) for use in conjunction with the Spectranetics CVX-300® Excimer Laser System (CVX-300) and are intended for use in patients with single or multivessel coronary artery disease (CAD) or SVG disease as a stand-alone modality or in conjunction with PCI techniques. 
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Device Success: Successful crossing of the Laser Catheter across the entire length of the stenotic lesion   NA 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 1 month post procedure 
TIMI Flow  1 month post procedure 
Lesion Morphology  1 month post procedure 
Device-related complications  NA 
Procedure-related complications  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/09/2017 
Date of Study Completion (India) 21/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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).

 A total of 30 patients with Single or Multi vessel Coronary Artery Disease (CAD) will be enrolled at up to 5 investigational sites in India.

 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 the entire length of the stenotic lesion

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

 Safety Endpoints are :

·         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

·         Lesion Morphology

·         Device-related complications

·         Procedure-related complications

 
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