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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree.
Global Health Private Limited, Medanta - The Medicity
Gurgaon, Haryana, India
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore, Karnataka, India
Lilavati Hospital and Research Centre
Bāndrā, Mumbai, India
Escorts Heart Institute & Research Centre Limited
New Delhi, National Capital Territory of Delhi, India
Participants With Device Success During Procedure Defined as the Successful Crossing of the Laser Catheter Across the Entire Length of the Stenotic Lesion
Successful crossing of the Laser Catheter across the entire length of the stenotic lesion
Time frame: Procedure
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure
Target lesions with less than 50% residual stenosis after laser and adjunctive therapy.
Time frame: Procedure
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
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
TIMI Flow
To determine post-procedural TIMI Flow grade. Changes of TIMI Grade flow after Index Procedure by measuring pre-procedure TIMI grade flow and post-procedure TIMI grade flow. TIMI flow is a scoring system from 0-3 referring to levels of coronary blood flow assessed during percutaneous coronary angioplasty. TIMI flow was assessed before and after the procedure. TIMI grade flow 0-3 are as described below. * TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. * TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. * TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. * TIMI 3 is normal flow which fills the distal coronary bed completely.
Time frame: pre-procedure and post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
All Indian Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity
Tortuosity from coronary angiography
Time frame: Procedure
Lesion Morphology - Eccentricity of Coronary Lesion
Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)
Time frame: Procedure
Lesion Morphology - Contour as a Lesion Characteristic
Contour from coronary angiography
Time frame: Procedure
Lesion Morphology - Bifurcation (Branch or Division of Artery)
Bifurcation from coronary angiography
Time frame: Procedure
Participants With Device-related Complications During Procedure
To determine device related complications
Time frame: Procedure
Participants With Procedure-related Complications During Procedure
To determine procedure related complications
Time frame: Procedure