Ischemic Heart DiseaseRA-BIANCT05787886
Rotational Atherectomy: Long-term Results From a Single Center Experience
An observational study of Ischemic Heart Disease and Acute Coronary Syndrome, run by Medical University of Bialystok at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Acute Coronary Syndrome
- How many people
- 1,200 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2007to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease who were treated with rotational atherectomy.
Who may be able to join
- Patient ≥ 18 years old
- Lesions in target vessels requiring RA
- Patient accepting the appropriate follow-up as per study definition
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
Bialystok, 15-276
About this study
Official title: Clinical Outcomes of Percutaneous Coronary Intervention With Rotational Atherectomy: the Poland Single RA-BIA Registry
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.
Read the 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
- Keywords
- rotational atherectomy, rotablation
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of various endpoints
- 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.
Measured: 5 years
Secondary outcomes (1)
Procedural, Technical and Clinical Success
- 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 May 2007
- Primary completion31 Dec 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Kuzma, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787886
- Sponsor's protocol ID
- UMB-KKI-105
- Acronym
- RA-BIA
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Percutaneous Coronary Intervention With Rotational Atherectomy: the Poland Single RA-BIA Registry
- ClinicalTrials.gov ID
- NCT05787886
- Acronym / sponsor ID
- RA-BIA / UMB-KKI-105
- Conditions
- Ischemic Heart Disease, Acute Coronary Syndrome
- Keywords
- rotational atherectomy, rotablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 May 2007 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease who were treated with rotational atherectomy.
Key inclusion criteria (3 listed)
- Patient ≥ 18 years old
- Lesions in target vessels requiring RA
- Patient accepting the appropriate follow-up as per study definition
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of various endpoints
Time frame: 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.
1 secondary outcome
Procedural, Technical and Clinical Success
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Acute Coronary Syndrome, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of various endpoints (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.