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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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