2005 Participants Needed

Orbital Atherectomy vs. Angioplasty for Coronary Artery Disease

(ECLIPSE Trial)

Recruiting at 104 trial locations
KS
KS
LR
DH
SA
OR
EW
DS
Overseen ByDaniel Sherbet, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The 'Single-Operator' technique study suggests that the orbital atherectomy device can be safely and effectively used by a single operator, which may imply its potential effectiveness in treating coronary artery disease by removing blockages in the arteries.910111213

Who Is on the Research Team?

Ajay J. Kirtane, MD, Cardiovascular ...

Ajay Kirtane, MD

Principal Investigator

Columbia University Medical Center / New York-Presbyterian Hospital

PG

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

My heart condition is stable or I had a recent heart attack that's now stable.
Subject has signed the Institutional Review Board (IRB) or Ethics Committee (EC) approved ECLIPSE trial Informed Consent Form (ICF) prior to any trial related procedures

Exclusion Criteria

I have heart failure, shown by severe symptoms or test results.
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.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Orbital Atherectomy or Conventional Balloon Angioplasty prior to implantation of drug-eluting stents

Procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at 1 year

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Balloon Angioplasty
  • Orbital Atherectomy
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials
659
Recruited
420,000+
Founded
1888
Headquarters
Abbott Park, Illinois, USA
Known For
Medical Devices Innovation
Top Products
FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs
Dr. Etahn Korngold profile image

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford profile image

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

Trials
17
Recruited
7,300+

Cardiovascular Research Foundation, New York

Collaborator

Trials
28
Recruited
27,800+

Citations

Orbital exenterations: an 18-year experience from a single head and neck unit. [2011]
Orbital Exenteration for Advanced Periocular Adnexal Malignancies: Curative Versus Palliative Surgical Intent. [2022]
"Single-Operator" Technique for Advancing the Orbital Atherectomy Device. [2017]
Technical Note on Three- and Four-Wall Orbital Reconstructions With Patient-Specific Implants. [2022]
Accuracy of Orbital Shape Reconstruction-Comparative Analysis of Errors in Implant Shape Versus Implant Positioning: A Cadaveric Study. [2023]
Mid-term outcomes of consecutive 998 cases of coronary atherectomy in contemporary clinical practice. [2018]
Outcomes of patients with severely calcified aorto-ostial coronary lesions who underwent orbital atherectomy. [2019]
Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis. [2019]
Real-World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Orbital atherectomy safety and efficacy: A comparative analysis of ostial versus non-ostial calcified coronary lesions. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Procedural and Long-Term Ischemic Outcomes of Tight Subtotal Occlusions Treated with Orbital Atherectomy: An ORBIT II Subanalysis. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Orbital atherectomy of calcified coronary ostial lesions. [2023]
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