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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 presents with stable ischemic heart disease or acute coronary syndrome (NSTEMI or unstable angina), or stabilized recent STEMI (>48 hours prior to randomization procedure)
Subject is 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
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 belowSelect...
My heart condition is stable or I had a recent heart attack that's now stable.
Select...
I am 18 years old or older.
ECLIPSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
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
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.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
635 Previous Clinical Trials
403,230 Total Patients Enrolled
102 Trials studying Coronary Artery Disease
124,300 Patients Enrolled for Coronary Artery Disease
Cardiovascular Research Foundation, New YorkOTHER
24 Previous Clinical Trials
24,742 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
14,707 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure, shown by severe symptoms or test results.My heart condition is stable or I had a recent heart attack that's now stable.You are allergic to the ingredients in the atherectomy lubricant, such as soybean oil, egg yolk phospholipids, glycerin, and sodium hydroxide.I have a bleeding disorder or won't accept a blood transfusion.I am scheduled for a procedure using a specific type of heart artery support.I had a stroke or a mini-stroke in the last 6 months.I am currently taking antibiotics for an infection.I have not had a PCI in the target vessel or its branches within the last 12 months.You are expected to live for less than 12 months.I don't plan any heart surgery within a year except for a possible PCI.I cannot take certain blood thinning medications for 6 months after my heart procedure.I am currently pregnant.I am scheduled for or currently receiving chemotherapy around the time of the study.I am 18 years old or older.I have had a heart transplant.I had a heart procedure (PCI) that didn't work or caused problems within the last 30 days.I had a heart valve surgery within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Orbital Atherectomy (OA)
- Group 2: Conventional Balloon Angioplasty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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