Actively Recruiting
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Led by Fundación EPIC · Updated on 2026-05-01
200
Participants Needed
8
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Moderately or severely calcified bifurcation coronary lesions with lateral vessel diameter 2 mm or larger
- Candidates for PCI with coronary stent implantation
- Ability to have adequate clinical follow-up for 1 year
- Signed informed consent to participate in the study
You will not qualify if you...
- Previous revascularization of the target artery within 9 months before the procedure
- Contraindications to Orbital Atherectomy including cardiogenic shock, thrombotic lesions, vascular graft disease, remaining vessel disease, severe left ventricular dysfunction, or allergy to washing serum components
- Life expectancy less than one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
H. G.U. de ALICANTE DR. BALMIS
Alicante, Spain, 03010
Actively Recruiting
2
Hospital Del Mar
Barcelona, Spain, 08003
Actively Recruiting
3
H. de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
4
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
5
Hospital Universitario La Paz
Fuencarral-El Pardo, Spain, 28046
Actively Recruiting
6
Hospital Universitario Lucus Augusti
Lugo, Spain, 270003
Actively Recruiting
7
Hospital Universitario La Luz
Madrid, Spain, 28003
Actively Recruiting
8
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
J
JORGE PALAZUELOS, MD, PhD
CONTACT
F
FUNDACION EPIC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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