MedTrace Logo

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

NCT03108456 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2005

Last updated 2023-10-06

No results posted yet for this study

Summary

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Conditions

Interventions

DEVICE

Orbital Atherectomy

Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation

DEVICE

Balloon

Vessel preparation with conventional and/or specialty balloons

Sponsors & Collaborators

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ajay Kirtane, MD, SM · Columbia University Medical Center / New York-Presbyterian Hospital

  • Philippe Généreux, MD · Morristown Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2024-06-12
Completion
2025-06-12
FDA Device
Yes

Countries

  • United States

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 NCT03108456 on ClinicalTrials.gov