Orbital Atherectomy vs. Angioplasty for Coronary Artery Disease

(ECLIPSE Trial)

Recruiting at 104 trial locations

Overseen By Daniel Sherbet, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Must not be taking: Chemotherapy, Antiplatelets, Anticoagulants, others

Disqualifiers: Pregnancy, Heart failure, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Procedure

2005 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{9 10 11 12 13}

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.

Research Team

Ajay Kirtane, MD

Principal Investigator

Columbia University Medical Center / New York-Presbyterian Hospital

Philippe Généreux, MD

Principal Investigator

Morristown Medical Center

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Orbital Atherectomy (OA) Active Control 1 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 Angioplasty Active Control 1 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.

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

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

Trials

17

Recruited

7,300+

Cardiovascular Research Foundation, New York

Collaborator

Trials

28

Recruited

27,800+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Orbital exenterations: an 18-year experience from a single head and neck unit. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Orbital Exenteration for Advanced Periocular Adnexal Malignancies: Curative Versus Palliative Surgical Intent. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

"Single-Operator" Technique for Advancing the Orbital Atherectomy Device. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Technical Note on Three- and Four-Wall Orbital Reconstructions With Patient-Specific Implants. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Orbital Shape Reconstruction-Comparative Analysis of Errors in Implant Shape Versus Implant Positioning: A Cadaveric Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Mid-term outcomes of consecutive 998 cases of coronary atherectomy in contemporary clinical practice. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes of patients with severely calcified aorto-ostial coronary lesions who underwent orbital atherectomy. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Real-World Multicenter Registry of Patients with Severe Coronary Artery Calcification Undergoing Orbital Atherectomy. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Orbital atherectomy safety and efficacy: A comparative analysis of ostial versus non-ostial calcified coronary lesions. [2023]

11. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Orbital atherectomy of calcified coronary ostial lesions. [2023]