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

Phase 3

Completed

• Conditions: Health Condition 1: null- Patients with Single or Multivessel Coronary Artery Disease (CAD)

• Registration Number: CTRI/2017/09/009768
• Lead Sponsor: Spectranetics Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

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 >=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.

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Device-related complicationsTimepoint: NA;Freedom from Major Adverse Cardiac Events (MACE) through hospital discharge and at one month. <br/ ><br>MACE is defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target Lesion Revascularization, Cardiac Tamponade and Life-threatening arrhythmias <br/ ><br>Timepoint: 1 month post procedure;Lesion MorphologyTimepoint: 1 month post procedure;Procedure-related complicationsTimepoint: NA;TIMI FlowTimepoint: 1 month post procedure