Registry Following Orbital Atherectomy Use in Calcified Heart Artery Blockages
Records outcomes of heart artery procedures using an orbital device for calcified blockages in adults.
Key facts
- Who runs it
- Miedziowe Centrum Zdrowia SA
- Where
- Legnica and Lubin, PolandSee the 2 sites
- Trial code
- Registry title
- Lower Silesian Orbital Atherectomy Registry (LOAR)
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 1 May 2022
- Expected to end
- 1 May 2027
- Type of study
- Observational
- Treatments tested
- PCI Facilitated with Orbital Atherectomy Device
- Record updated
- 21 August 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The registry is looking for adults with coronary artery disease who have moderately to severely calcified lesions in their heart arteries and are having a heart artery procedure (PCI) with an orbital atherectomy device.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Moderately to severely calcified lesions in the coronary arteries.
- Earlier treatment
- People whose target vessel was perforated after an earlier unsuccessful lesion preparation cannot join.
Main reasons for not taking part
- No patient consent
- Target vessel perforation due to previous unsuccessful lesion preparation
- Pregnancy
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- The presence of moderately to severely calcified lesions
Who cannot take part
- Target vessel perforation due to previous unsuccessful lesion preparation
- Lack of patient consent
- Pregnancy
Where in Poland
- Department of Cardiology, Provincial Specialized Hospital in LegnicaLegnica, PolandContact: Piotr Rola, M.D; PhDTaking people
- Department of Cardiology, The Copper Health Centre (MCZ)Lubin, PolandContact: Adrian Włodarczak, Assoc Prof.Taking people
About the trial
What the trial wants to find out
The Lower Silesian Orbital Atherectomy Registry (LOAR), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of the Orbital Atherectomy Device due to the presence of calcified lesion in coronary arteries. Data will be collected in two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland).
The group in the trial
- OA Intervention
All consecutive patients with moderate/ severely calcified coronary lesions who underwent PCI facilitated by the Orbital Atherectomy The decision to perform orbital atherectomy was left to the operator's dissertation after the detection of a moderate/severely calcified lesion. Angiographic calcification was classified as moderate when it involved between 30% and 50% of the reference lesion diameter, and severe when it occupied over 50% of the reference diameter. When the initial assessment was based on IVUS finding lesion had to reach at least 2 points in the IVUS calcium score. There were no angiographic exclusion criteria regarding lesion anatomy such as the length, tortuosity, severity, or location. All procedural features(use additional lesion preparation technique; stent implantation parameters, periprocedural pharmacological therapy, use of intravascular imaging along with the left ventricular support device) were left to the discretion of the operator.
Treatment: PCI Facilitated with Orbital Atherectomy Device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Safety and Efficacy of Orbital Atherectomy (OA) for Calcified Lesions in Patients With Coronary Artery Disease: The Lower Silesian Orbital Atherectomy Registry (LOAR)
- Plain-language title
- Registry Following Orbital Atherectomy Use in Calcified Heart Artery BlockagesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 August 2024