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Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

RecruitingNAAges 18 Years - anyAllFundación EPIC
NCT06736899 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients over 18 years of age and * Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and * Patients agree to participate in the study, by signing the Informed Consent. Exclusion Criteria: * Patients with revascularization of the artery to be treated within 9 months prior to the index procedure. * Patients with contraindication for the use of Orbital Atherectomy: * Patients in cardiogenic shock. * Patients with Thrombotic lesions. * Patients with Vascular graft disease. * Patients with remain vessel disease. * Patients with severe left ventricular dysfunction. * Patients allergic to the components of the washing serum (glide). * Patients with life expectancy less than one year.
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What it tests

  • Orbital Atherectomy System Treatment
  • Balloon System Treatment
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Where

9 sites
H. G.U. de ALICANTE DR. BALMIS
Alicante, Spain
Hospital Del Mar
Barcelona, Spain
H. de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Universitario La Luz
Madrid, Spain
Hospital Universitari de Salamanca
Salamanca, Spain

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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