Registry for patients undergoing coronary intervention with orbital atherectomy
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)
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regional Cardiology Center, The Copper Health Centre (MCZ), Academic / other |
| Locations | 2 sites (Legnica, Lower Silesian Voivodeship and 1 other locations) |
| Trial ID | NCT06451146 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients with moderate to severe calcification in coronary arteries who require PCI.
Not a fit: Patients who lack consent, have target vessel perforation from previous procedures, or are pregnant will not benefit from this registry.
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 performed: While this registry approach is observational, similar studies have shown promising results in assessing the efficacy of atherectomy devices in coronary interventions.
Eligibility criteria
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 this trial is running
Legnica, Lower Silesian Voivodeship and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.