Orbital Atherectomy vs. Angioplasty for Coronary Artery Disease
(ECLIPSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial will compare a high-speed rotating device to remove hard calcium deposits with a traditional method for patients with severely calcified artery issues before placing special stents. The new device is designed to help treat these calcified areas.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have a contraindication to certain therapies, so it's best to discuss your medications with the trial team.
Is orbital atherectomy generally safe for humans?
Research shows that orbital atherectomy has been evaluated for safety in patients with severe coronary artery calcification, and it is generally considered safe in these cases. Multiple studies have assessed its safety in different types of calcified coronary lesions, indicating it is feasible and safe for use in humans.12345
How does orbital atherectomy differ from other treatments for coronary artery disease?
Orbital atherectomy is unique because it is specifically designed to treat severely calcified coronary lesions by modifying the calcified plaque before placing a stent, which can be more challenging with traditional balloon angioplasty. This makes it particularly useful for patients with heavily calcified arteries, where other treatments might not be as effective.45678
What data supports the effectiveness of the treatment Orbital Atherectomy vs. Angioplasty for Coronary Artery Disease?
Who Is on the Research Team?
Ajay Kirtane, MD
Principal Investigator
Columbia University Medical Center / New York-Presbyterian Hospital
Philippe Généreux, MD
Principal Investigator
Morristown Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either Orbital Atherectomy or Conventional Balloon Angioplasty prior to implantation of drug-eluting stents
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at 1 year
What Are the Treatments Tested in This Trial?
Interventions
- Balloon Angioplasty
- Orbital Atherectomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Cardiovascular Systems Inc
Lead Sponsor
Cardiovascular Research Foundation, New York
Collaborator