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

NCT ID: NCT03284229

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2018-05-21

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Excimer Laser Coronary Atherectomy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ELCA Coronary Laser Atherectomy Catheters (OTW and RX)

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CBCC-VIBGYOR Research Pvt. Ltd.

OTHER

Sponsor Role: collaborator

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Krygier, MBA

Role: STUDY_DIRECTOR

Spectranetics Corporation

Locations

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

Bāndra, Mumbai, India

Escorts Heart Institute & Research Centre Limited

New Delhi, National Capital Territory of Delhi, India

All Indian Institute of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Related Links

http://www.spectranetics.com/resources/ifu-library/

ELCA laser system and catheter IFUs

Other Identifiers

ELCA-1016

Identifier Type: -

Identifier Source: org_study_id