Orbital atherectomy versus standard balloon strategy for calcified coronary bifurcation lesions

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

This study tests whether using orbital atherectomy before stenting helps adults with moderately or severely calcified coronary bifurcation lesions get better stent results than the standard balloon-first approach.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación EPIC (other)
• Locations: 8 sites (Alicante and 7 other locations)
• Trial ID: NCT06736899 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, prospective randomized study comparing initial plaque modification with orbital atherectomy plus stent implantation versus conventional balloon angioplasty plus stent implantation for calcified coronary bifurcation lesions. Patients with moderately or severely calcified bifurcation lesions (side branch ≥2 mm) are randomized to one of the two strategies and followed with angiography and optical coherence tomography (OCT) to document stent expansion, apposition, and related outcomes. The trial collects safety and efficacy outcomes, including imaging endpoints and clinical events, with planned clinical follow-up out to one year. The goal is to determine whether orbital atherectomy facilitates provisional stenting and reduces complications related to underexpanded or malapposed stents.

Who should consider this trial

Good fit: Adults aged 18 or older with moderately or severely calcified coronary bifurcation lesions (side branch ≥2 mm) who are candidates for PCI with stent implantation and can commit to one-year follow-up are ideal candidates.

Not a fit: Patients with contraindications to orbital atherectomy—such as thrombotic lesions, vascular graft disease, recent revascularization within nine months, cardiogenic shock, severe left ventricular dysfunction, allergy to required device components, or life expectancy under one year—are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the approach could improve stent expansion and reduce restenosis or stent thrombosis in calcified bifurcation lesions.

How similar studies have performed: Atherectomy devices have shown promise for improving stent expansion in heavily calcified coronary lesions, but randomized data specifically focused on calcified bifurcation lesions are limited, making this a relatively novel, targeted comparison.

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.

Where this trial is running

Alicante and 7 other locations

• 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 Universitario Virgen del Rocio — Seville, Spain (RECRUITING)

Study contacts

• Study coordinator: JORGE PALAZUELOS, MD, PhD

Conditions: Coronary Artery Disease, Coronary Disease, Orbital Atherectomy, Percutaneous Coronary Intervention, Bifurcation, Side Branch Treatment: Mid-term results