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

Coronary Artery Disease Clinical Trial

— ELCA-CAD  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284229
• Other study ID #: ELCA-1016
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: July 2020
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Excimer Laser Coronary Atherectomy
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Spectranetics Corporation	CBCC-VIBGYOR Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure
Primary	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.	Procedure
Primary	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.	30 days
Secondary	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.	pre-procedure and post-procedure
Secondary	Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity	Tortuosity from coronary angiography	Procedure
Secondary	Lesion Morphology - Eccentricity of Coronary Lesion	Eccentricity from coronary angiography as concentric (symmetric) or eccentric (asymmetric)	Procedure
Secondary	Lesion Morphology - Contour as a Lesion Characteristic	Contour from coronary angiography	Procedure
Secondary	Lesion Morphology - Bifurcation (Branch or Division of Artery)	Bifurcation from coronary angiography	Procedure
Secondary	Participants With Device-related Complications During Procedure	To determine device related complications	Procedure
Secondary	Participants With Procedure-related Complications During Procedure	To determine procedure related complications	Procedure

External Links

•   ELCA laser system and catheter IFUs