RecruitingNot ApplicableNCT06736899

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Sponsor

Fundación EPIC

Enrollment

200 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Disease Coronary Artery Disease

Summary

Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Balloon System Treatment and a medical device called Orbital Atherectomy System Treatment for people with coronary artery disease and coronary disease. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOrbital Atherectomy System Treatment

Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.

DEVICEBalloon System Treatment

Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.