An observational study in Ischemic Heart Disease and Acute Coronary Syndrome, sponsored by Medical University of Bialystok. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Medical University of Bialystok · Observational
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with coronary artery disease who were treated with rotational atherectomy.
Exclusion Criteria:
Rate of various endpoints
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.
Time frame: 5 years
Procedural, Technical and Clinical Success
1. Procedural Success Defined as successful use of rotational atherectomy 2. Technical Success Defined as a successful rotational atherectomy with stent implantation 3. 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.
Time frame: 5 years
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Bialystok