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

NCT03284229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-09-18

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • CBCC-VIBGYOR Research Pvt. Ltd.

    collaborator OTHER

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Karen Krygier, MBA · Spectranetics Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2018-05-21
Completion
2018-05-21
FDA Device
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284229 on ClinicalTrials.gov