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 compares two methods for treating severely blocked heart arteries: orbital atherectomy and conventional balloon angioplasty. Orbital atherectomy uses a special tool to shave away hard plaque in arteries, while balloon angioplasty uses a balloon to open them. Researchers aim to determine which method is superior before placing a drug-eluting stent, which releases medication to keep the artery open longer. Individuals with stable or recently worsened heart disease who haven't had recent unsuccessful heart procedures might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding which treatment method may be more effective for future patients.
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 prior data suggests that these techniques are safe for treating coronary artery disease?
Research has shown that the Orbital Atherectomy System (OAS), also known as the Diamondback 360, has been tested for safety and effectiveness. One study found that 19.4% of patients experienced major heart-related issues, such as heart attacks or the need for another procedure, within two years after treatment. These results are typical for treatments of serious heart conditions.
The traditional balloon angioplasty is a common method approved by the FDA for treating blocked heart arteries. It is considered safe and is often used to prepare arteries before placing drug-eluting stents, which help keep arteries open.
Both treatments have been used in patients with heart conditions, and their safety is well-documented. While Orbital Atherectomy and balloon angioplasty carry risks, healthcare professionals manage these risks carefully.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they present unique approaches for managing coronary artery disease. Orbital Atherectomy stands out because it uses the Diamondback 360® Coronary Orbital Atherectomy System to precisely prepare the artery by sanding away calcified plaque before placing a stent. This is different from the conventional balloon angioplasty, which simply inflates a balloon to widen the artery but may not be as effective in heavily calcified vessels. The orbital atherectomy's ability to better prepare complex lesions potentially leads to improved stent placement and long-term outcomes.
What evidence suggests that this trial's treatments could be effective for coronary artery disease?
This trial will compare Orbital Atherectomy with Conventional Balloon Angioplasty for coronary artery disease. Research has shown that orbital atherectomy can effectively reduce plaque in the heart's arteries. It employs a spinning, diamond-coated tool to clear the way for stent placement, which is crucial for treating very hardened arteries. Studies have found that using this method before placing drug-coated stents can lead to fewer complications. Conversely, conventional balloon angioplasty, another treatment option in this trial, is widely used and has a strong track record of preparing arteries for stents, though it may not be as effective on very hardened areas as orbital atherectomy. Both treatments aim to improve blood flow, but the best choice depends on the specific condition of the artery.678910
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
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?
2
Treatment groups
Active Control
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.
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
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
Citations
Long‐Term Effectiveness of a Stent‐Less Strategy With ...
Drug‐coated balloon (DCB) is an option for in‐stent restenosis, and has also shown promise for small‐calibre coronary artery disease. We ...
Long-term efficacy of drug-coated balloon-based treatment ...
Data from the pooled analysis of contemporary DES trials indicate an average estimated risk of stent-related adverse events of 2% per year, ...
Drug-Coated Balloons in the Management of Coronary ...
DCBs provide improved long-term vessel patency compared with conventional balloon angioplasty and may be comparable to drug-eluting stents ...
a 12-month comparative study with drug-eluting stents - PMC
Clinical and angiographic outcomes of coronary dissection after paclitaxel-coated balloon angioplasty for small vessel coronary artery disease.
Drug-Coated Balloons-Based Intervention for Coronary ...
Recent studies show that DCBs can be effective and safe across various coronary artery diseases (CADs) when lesions are adequately prepared.
fda summary of safety and effectiveness data (ssed)
Three (3) in vivo studies were performed to demonstrate performance and safety of the. DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) ...
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cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/percutaneous-coronary-intervention/atherectomy-systems/diamondback-360-precision.htmlDiamondback 360 | Abbott
Orbital Atherectomy is a First-line Approach for Optimal Vessel Prep in Complex PCI Cases with Severe Calcium. Coronary calcium tends to be underestimated.
Patient Selection and Procedural Considerations for ...
This article summarises currently available publications on orbital atherectomy (Cardiovascular Systems Inc.) and compares them with rotational atherectomy.
NCT02132611 | Coronary Orbital Atherectomy System Study
This is a prospective, single-arm, multi-center, global study designed to evaluate performance of the Diamondback 360® Coronary Orbital Atherectomy System Micro ...
Device to Sand Away Severe Calcium in Coronary Arteries ...
The new data followed patients to two years after their procedure. Results showed 19.4 percent of patients experienced a major adverse cardiac event (MACE), ...
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