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

NCT03284229 | Completed Results FDA Device

• 1 other identifier: ELCA-1016
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease

Keywords

ELCA; Coronary Artery Disease; India

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• TIMI Flow

  pre-procedure and post-procedure

• Lesion Morphology - Coronary Tortuosity Based on Degree of Tortuosity

  Procedure

• Lesion Morphology - Eccentricity of Coronary Lesion

  Procedure

• Lesion Morphology - Contour as a Lesion Characteristic

  Procedure

• Lesion Morphology - Bifurcation (Branch or Division of Artery)

  Procedure

Study Arms (1)

Excimer Laser Coronary Atherectomy

EXPERIMENTAL

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.

Device: Excimer Laser Coronary Atherectomy

Interventions

Excimer Laser Coronary Atherectomy 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.

Also known as: ELCA Coronary Laser Atherectomy Catheters (OTW and RX)

Excimer Laser Coronary Atherectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Spectranetics Corporation: lead
• CBCC-VIBGYOR Research Pvt. Ltd.: collaborator

Study Sites (5)

Global Health Private Limited, Medanta - The Medicity

Gurgaon, Haryana, 122001, India

Location

Sri Jayadeva Institute of Cardiovascular Sciences and Research

Bangalore, Karnataka, 560069, India

Location

Lilavati Hospital and Research Centre

Bandra, Mumbai, 100050, India

Location

Escorts Heart Institute & Research Centre Limited

New Delhi, National Capital Territory of Delhi, 160011, India

Location

All Indian Institute of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, India

Location

Related Links

• ELCA laser system and catheter IFUs

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Spectranetics Corporation
• Organization: Spectranetics Corporation

Ami.Sood@philips.com

719-447-2211

Study Officials

• Karen Krygier, MBA

  Spectranetics Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: As per the 25th SEC (Cardiovascular \& Renal) meeting which deliberated the proposals on 30-10-2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging study in Indian Population at least 25 patients with coronary artery disease. The directorate suggested that the sponsor submit a protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 eligible patients across 05 sites as a Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA) in single or multi-vessel coronary artery disease.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 15, 2017
• Study Start: September 20, 2017
• Primary Completion: May 21, 2018
• Study Completion: May 21, 2018
• Last Updated: September 18, 2020
• Results First Posted: September 18, 2020

Record last verified: 2020-07

Locations

IN (5)