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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Spectranetics Corporation
- Enrollment
- 28
- Locations
- 5
- Primary Endpoint
- Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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). 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)