NCT06736899 Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
| NCT ID | NCT06736899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-10-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06736899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06736899 currently recruiting?
Yes, NCT06736899 is actively recruiting participants. Contact the research team at jpalaz@gmail.com for enrollment information.
Where is the NCT06736899 trial being conducted?
This trial is being conducted at Alicante, Spain, Barcelona, Spain, Barcelona, Spain, Córdoba, Spain and 4 additional locations.
Who is sponsoring the NCT06736899 clinical trial?
NCT06736899 is sponsored by Fundación EPIC. The trial plans to enroll 200 participants.