RecruitingNot ApplicableNCT06736899

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Sponsor

Fundación EPIC

Enrollment

200 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Disease Coronary Artery Disease

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria9

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.

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Interventions

DEVICEOrbital 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.

DEVICEBalloon 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.