What side effects are associated with this type of intervention?

Common treatments for Coronary Artery Disease (CAD) similar to Orbital Atherectomy include conventional balloon angioplasty and drug-eluting stents (DES). The known side effects of these treatments can include bleeding, infection, and blood vessel damage at the catheter insertion site. There is also a risk of restenosis, where the artery narrows again, and thrombosis, which is the formation of a blood clot within the stent. Additionally, patients may experience allergic reactions to the stent material or the drugs used in DES. These side effects should be discussed with a healthcare provider to weigh the benefits and risks of the treatment options.

What prior FDA approvals exist?

Orbital Atherectomy, which mechanically sands away calcium deposits in coronary arteries, is a specialized treatment for severely calcified coronary lesions. The FDA has approved this technique, as evidenced by the ORBIT II trial, which demonstrated its safety and efficacy. Other FDA-approved treatments for CAD include conventional balloon angioplasty and the implantation of drug-eluting stents (DES), which help keep the arteries open and prevent restenosis. These treatments are often used in combination to manage complex coronary artery disease effectively.

What other types of research exist?

Promising novel alternatives to Orbital Atherectomy for treating calcified coronary lesions in CAD patients include: 1) Intravascular Lithotripsy (IVL), which uses sonic pressure waves to fracture calcium deposits, making stent deployment easier; 2) Laser Atherectomy, which employs laser energy to vaporize calcium and other plaque components; and 3) Rotational Atherectomy, which uses a high-speed rotating burr to ablate calcified plaque. These methods are gaining traction due to their efficacy and safety profiles.

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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

Must not have

Subject has a history of a stroke or transient ischemic attack (TIA) within six (6) months prior to randomization, or any permanent neurologic deficit

Subject has evidence of an active infection on the day of the randomization procedure requiring oral or intravenous antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart condition is stable or I had a recent heart attack that's now stable.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stroke or a mini-stroke in the last 6 months.

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I am currently taking antibiotics for an infection.

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I have a bleeding disorder or won't accept a blood transfusion.

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I am scheduled for a procedure using a specific type of heart artery support.

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I cannot take certain blood thinning medications for 6 months after my heart procedure.

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I am currently pregnant.

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I am scheduled for or currently receiving chemotherapy around the time of the study.

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I have had a heart transplant.

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I had a heart procedure (PCI) that didn't work or caused problems within the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute Minimum Stent Area (MSA)

Target Vessel Failure (TVF)

Secondary study objectives

Procedural Success

Strategy Success

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Coronary Artery Disease (CAD) include mechanical and pharmacological approaches. Orbital Atherectomy, which mechanically sands away calcium deposits in the arteries, is crucial for improving blood flow and facilitating the placement of drug-eluting stents (DES). Balloon angioplasty and stenting are other mechanical methods that widen and keep arteries open. Pharmacological treatments, such as statins and antiplatelet drugs, lower LDL cholesterol and prevent blood clots, respectively. These treatments are vital for restoring and maintaining adequate blood flow to the heart, thereby reducing the risk of heart attacks and other cardiovascular events.