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Orbital Atherectomy vs. Angioplasty for Coronary Artery Disease (ECLIPSE Trial)

N/A
Waitlist Available
Led By Ajay Kirtane, MD, SM
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is 18 years of age or older
Subject presents with stable ischemic heart disease or acute coronary syndrome (NSTEMI or unstable angina), or stabilized recent STEMI (>48 hours prior to randomization procedure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
No Placebo-Only Group

ECLIPSE Trial Summary

This trial will compare two methods for treating severely calcified heart arteries before implantation of a drug-eluting stent.

Who is the study for?
This trial is for adults with stable heart disease or recent heart attacks who've consented to the study. It's not for those with a short life expectancy, planned cardiac interventions within a year (except certain PCIs), contraindications to antiplatelet/anticoagulant therapy, cognitive issues affecting participation, pregnancy, chemotherapy within 30 days of the procedure, sensitivity to contrast media that can't be pre-medicated, prior heart transplant or PCI in target vessel within a year.Check my eligibility
What is being tested?
The ECLIPSE Trial compares Orbital Atherectomy and conventional balloon angioplasty before placing drug-eluting stents in severely calcified arteries. Participants are randomly assigned one of these treatments to see which is more effective at preparing arteries for stent placement.See study design
What are the potential side effects?
Potential side effects may include bleeding due to dual antiplatelet therapy or anticoagulants required post-procedure; complications from the angioplasty such as artery dissection or blockage; reactions related to contrast media used during procedures; and general risks associated with invasive cardiac procedures.

ECLIPSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My heart condition is stable or I had a recent heart attack that's now stable.

ECLIPSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Minimum Stent Area (MSA)
Target Vessel Failure (TVF)
Secondary outcome measures
Procedural Success
Strategy Success

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

ECLIPSE Trial Design

2Treatment groups
Active Control
Group I: Orbital Atherectomy (OA)Active Control1 Intervention
The Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy (OA) vessel preparation prior to implantation of a drug-eluting stent.
Group II: Conventional Balloon AngioplastyActive Control1 Intervention
Coronary balloons cleared or approved for commercial use by the Food and Drug Administration will be used for conventional balloon angioplasty prior to implantation of a drug-eluting stent.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
634 Previous Clinical Trials
400,733 Total Patients Enrolled
102 Trials studying Coronary Artery Disease
124,300 Patients Enrolled for Coronary Artery Disease
Cardiovascular Research Foundation, New YorkOTHER
23 Previous Clinical Trials
23,118 Total Patients Enrolled
10 Trials studying Coronary Artery Disease
13,083 Patients Enrolled for Coronary Artery Disease
Cardiovascular Systems IncLead Sponsor
16 Previous Clinical Trials
5,292 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
843 Patients Enrolled for Coronary Artery Disease

Media Library

Balloon Angioplasty Clinical Trial Eligibility Overview. Trial Name: NCT03108456 — N/A
Coronary Artery Disease Research Study Groups: Orbital Atherectomy (OA), Conventional Balloon Angioplasty
Coronary Artery Disease Clinical Trial 2023: Balloon Angioplasty Highlights & Side Effects. Trial Name: NCT03108456 — N/A
Balloon Angioplasty 2023 Treatment Timeline for Medical Study. Trial Name: NCT03108456 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How large is the current participant pool in this research project?

"To ensure the accuracy of this trial's results, 2000 qualified individuals are needed as participants. Patients can join from many different locations such as Penn Presbyterian Medical Center in Philadelphia and U of L Health in Louisville."

Answered by AI
Recent research and studies
~70 spots leftby Jun 2024