Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Launched by FUNDACIÓN EPIC · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two different methods of treating coronary artery disease, specifically focusing on patients with calcified bifurcation lesions—areas where the arteries branch and have become hard due to calcium buildup. In the study, patients will be randomly assigned to one of two treatment groups: one group will receive a conventional treatment involving a balloon and a stent, while the other group will start with a procedure called Orbital Atherectomy (OA) to remove the calcium before getting the stent. The goal is to see which method is more effective and safer, using advanced imaging techniques to closely examine the results.

To participate in this trial, candidates must be over 18 years old and have specific types of blockages in their arteries that require treatment with a stent. They should also be able to commit to follow-up visits for a year after the procedure. However, certain patients may not qualify, such as those who have had recent procedures on the same artery or those with serious health issues. If eligible, participants can expect to be closely monitored throughout the study, and their safety and health outcomes will be carefully assessed. This trial aims to improve treatment options for patients with complex coronary artery disease.

Gender

ALL

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.