Rotational Atherectomy: Long-term Results From a Single Center Experience

NCT ID: NCT05787886

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-01
• Study Completion Date: 2025-12-31

Brief Summary

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

Detailed Description

Severe coronary artery calcifications occur in about 10% of patients undergoing percutaneous coronary intervention (PCI). They constitute a strong independent predictor of an adverse cardiovascular event. Even though the risk factors and pathomechanisms leading to severe coronary calcification are well understood, the options for effective treatment remain insufficient.

In the presence of severe calcification, standard PCI has inferior immediate and long-term outcomes. In this situation, advanced lesion modification techniques are indispensable to improve PCI outcomes. Dedicated balloons and essentially ablative techniques are available. Rotational atherectomy (RA) is the oldest and best-recognized ablative technique. It is generally acknowledged that superficial modification of calcified atherosclerotic lesions is an optimal mechanism of action in RA.

The RA-BIA Registry is a single-center observational study. The study included consecutive patients from 2008 who met inclusion criteria and were treated with RA. The main aim of the study is to assess the efficacy of rotational atherectomy.

The primary endpoints were device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, TLR, and target vessel MI), TVR, MI, and cardiac death. TVR and TLR were defined according to the definitions of endpoints for clinical trials. The secondary endpoints were the clinical success rate of the RA procedure (defined as successful revascularization of all treated lesions and the incidence of in-hospital complications including coronary perforation, coronary dissection, coronary low flow or no flow, emergency CABG, tamponade, MI, stroke or transient ischemic attack (TIA), bleeding events (according to the Bleeding Academic Research Consortium [BARC] classification and death.

Conditions

Ischemic Heart Disease; Acute Coronary Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient ≥ 18 years old

2. Lesions in target vessels requiring RA

3. Patient accepting the appropriate follow-up as per study definition

Exclusion Criteria

1. Patient age < 18 years

2. Patients who previously participated in this study.

3. Pregnant and/or breastfeeding females or females who intend to become pregnant.

4. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) .

5. The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Bialystok

OTHER

Sponsor Role: lead

Responsible Party

Lukasz Kuzma

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, , Poland

Countries

Poland

Other Identifiers

UMB-KKI-105

Identifier Type: -

Identifier Source: org_study_id