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Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Sponsor: Fundación EPIC
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).
Official title: Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-10-23
Completion Date
2026-12-31
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Orbital 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.
Balloon 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.
Locations (4)
H. G.U. de ALICANTE DR. BALMIS
Alicante, Spain
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Universitario La Luz
Madrid, Spain