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

Sponsor

Medical University of Bialystok (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05787886

Collaborator

(none)

1,200

Enrollment

Location

Anticipated Duration (Months)

27.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Acute Coronary Syndrome

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 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1200 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Clinical Outcomes of Percutaneous Coronary Intervention With Rotational Atherectomy: the Poland Single RA-BIA Registry

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Rate of various endpoints [5 years]
1. Rate of the device-oriented composite end point (DOCE) defined as a composite of cardiac death, target Lesion Revascularization (TLR), and target vessel MI), Target Vessel Revascularization (TVR), myocardial infraction (MI), and cardiac death.

Secondary Outcome Measures

Procedural, Technical and Clinical Success [5 years]
Procedural Success Defined as successful use of rotational atherectomy Technical Success Defined as a successful rotational atherectomy with stent implantation Clinical Success 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 ischaemic attack (TIA), bleeding events (according to the Bleeding Academic Research Consortium [BARC] classification and death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient ≥ 18 years old
Lesions in target vessels requiring RA
Patient accepting the appropriate follow-up as per study definition

Exclusion Criteria:

Patient age < 18 years
Patients who previously participated in this study.
Pregnant and/or breastfeeding females or females who intend to become pregnant.
Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) .
The subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.