Registry for patients undergoing coronary intervention with orbital atherectomy
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)
Run by Miedziowe Centrum Zdrowia SA · NCT06451146 · Data updated 2026-11-12
This study is collecting information on patients with hard-to-treat heart blockages who are getting a specific procedure called orbital atherectomy to see how safe and effective it is.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Miedziowe Centrum Zdrowia SA Academic / other |
| Locations | 2 sites (Legnica, Lower Silesian Voivodeship and 1 other locations) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | August 21, 2024 |
| Trial ID | NCT06451146 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are patients with moderate to severe calcification in coronary arteries who require PCI.
✕Probably not a fit
Patients who lack consent, have target vessel perforation from previous procedures, or are pregnant will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Lower Silesian Orbital Atherectomy Registry (LOAR) is an observational registry that collects data on patients with severely calcified coronary lesions who undergo percutaneous coronary intervention (PCI) using the Orbital Atherectomy Device. The study involves two cardiac centers in Poland, where consecutive cases are documented to assess safety and efficacy. Patients are selected based on clinical indications and the severity of calcification, which is evaluated through angiographic or intravascular imaging techniques. Informed consent is obtained from all participants after discussing the risks and benefits of the procedure.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of the safety and efficacy of orbital atherectomy in treating calcified coronary lesions, potentially improving patient outcomes.
How similar studies have gone: While this registry approach is observational, similar studies have shown promising results in assessing the efficacy of atherectomy devices in coronary interventions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The presence of moderately to severely calcified lesions. Exclusion Criteria: * Lack of patient consent * Target vessel perforation due to previous unsuccessful lesion preparation * Pregnancy
Where it's running
-
Department of Cardiology, Provincial Specialized Hospital in Legnica
Legnica, Lower Silesian Voivodeship, Poland Recruiting -
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Piotr Rola, MD; PhD
- Email: piotr.rola@gmail.com
- Phone: +48767211446
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.