Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
Patients in cardiogenic shock.
Patients with Thrombotic lesions.
Patients with Vascular graft disease.
Trial design
Treatments tested in this trial
- Orbital Atherectomy System Treatment
- Balloon System Treatment
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
8H. G.U. de ALICANTE DR. BALMIS03010, Alicante Spain
H. de La Santa Creu I Sant Pau08041, Barcelona Spain
Hospital Del Mar08003, Barcelona Spain
Hospital Universitario Reina Sofia14004, Córdoba Spain
Sponsors and collaborators
Fundación EPIC
Lead sponsor
Source ClinicalTrials.gov