Clinical trial NCT05787886: Rotational Atherectomy: Long-term Results From a Single Center Experience
Official title: Clinical Outcomes of Percutaneous Coronary Intervention With Rotational Atherectomy: the Poland Single RA-BIA Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ischemic Heart Disease
Acute Coronary Syndrome
Keywords: rotational atherectomy
rotablation
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease who were treated with rotational atherectomy.

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.

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.

Primary outcomes:
measure: Rate of various endpoints
timeFrame: 5 years
Secondary outcomes:
measure: Procedural, Technical and Clinical Success
timeFrame: 5 years
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
Study officials:
References: