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Clinical Trials in Spain / NCT06736899
Recruiting Not applicable

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

NCT06736899 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación EPIC
Phase
Not applicable
Started
2025-10-23
Last updated
2026-07-08

Condition(s) studied

Coronary Artery DiseaseCoronary Disease

Investigational drug(s) / intervention(s)

Orbital Atherectomy System TreatmentBalloon System Treatment

Orbital Atherectomy System Treatment: Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.

Balloon System Treatment: Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

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

More Fundación EPIC trials in Spain

Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients Active, not recruiting
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions Active, not recruiting
Cross-over Study of Coronary Risk Factors With a Polypill Recruiting
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients Active, not recruiting
Sequent Extended Study Active, not recruiting

Other trials for the same condition

First in Men Study: BIOMAG-I Active, not recruiting
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions Active, not recruiting
Cross-over Study of Coronary Risk Factors With a Polypill Recruiting
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients Active, not recruiting
Sequent Extended Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06736899 on ClinicalTrials.gov ↗ ← All trials in Spain