Orbital atherectomy versus standard balloon strategy for calcified coronary bifurcation lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: JORGE PALAZUELOS, MD, PhD
• Email: jpalaz@gmail.com
• Phone: 0034659768506

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.