Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Device: Excimer Laser Coronary Atherectomy

Registration Number: NCT03284229

Lead Sponsor: Spectranetics Corporation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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
Patients known to be suffering from substance abuse (alcohol or drug)
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
Patients not willing to provide written informed consent
In the investigators opinion subjects will not be able to comply with the follow-up requirements.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Excimer Laser Coronary Atherectomy	Excimer Laser Coronary Atherectomy	ELCA® in patients with single or multivessel CAD either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA). The entire procedure will be carried out as per the site routine practice and the device will be used as per the 'Instruction for Use'. Treating physicians/study investigators will be trained by the study Sponsor on the study protocol and procedures prior to clinical investigation procedure. Subject preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted.

Primary Outcome Measures

Name	Time	Method
Participants With Procedural Success Defined as Target Lesions With Less Than 50% Residual Stenosis After Laser and Adjunctive Therapy During Procedure	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	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	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 Outcome Measures

Name	Time	Method
Participants With Device-related Complications During Procedure	Procedure	To determine device related complications
Lesion Morphology - Bifurcation (Branch or Division of Artery)	Procedure	Bifurcation from coronary angiography
Participants With Procedure-related Complications During Procedure	Procedure	To determine procedure related complications
Lesion Morphology - Contour as a Lesion Characteristic	Procedure	Contour from coronary angiography
TIMI Flow	pre-procedure and post-procedure	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.
Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity	Procedure	Tortuosity from coronary angiography
Lesion Morphology - Eccentricity of Coronary Lesion	Procedure	Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)

Trial Locations

Locations (5): Escorts Heart Institute & Research Centre Limited
🇮🇳
New Delhi, Delhi, India
Lilavati Hospital and Research Centre
🇮🇳
Bandra, Mumbai, India
All Indian Institute of Medical Sciences (AIIMS)
🇮🇳
New Delhi, Delhi, India
Sri Jayadeva Institute of Cardiovascular Sciences and Research
🇮🇳
Bangalore, Karnataka, India
Global Health Private Limited, Medanta - The Medicity
🇮🇳
Gurgaon, Haryana, India