Tests orbital atherectomy before stenting in calcified heart artery forks
Compares a plaque-cutting device with balloons in adults with calcified coronary artery bifurcations.
Plain-language title generated from the registry record
Registry title: Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Key facts
- Where
- Alicante, Barcelona, Córdoba, Fuencarral-El Pardo, Lugo, Madrid, Salamanca, and Seville, SpainSee the 9 sites
Where in Spain
- H. G.U. de ALICANTE DR. BALMISAlicante, SpainTaking people
- H. de la Santa Creu I Sant PauBarcelona, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital Universitario La PazFuencarral-El Pardo, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital Universitario La LuzMadrid, SpainTaking people
- Hospital Universitari de SalamancaSalamanca, SpainTaking people
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT06736899
- Record updated
- 8 July 2026
- Original description
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).Read full original descriptionShow less
Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
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).
Inclusion: 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: 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.