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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The presence of moderately to severely calcified lesions.

Locations
Other Locations
Poland
Department of Cardiology, Provincial Specialized Hospital in Legnica
RECRUITING
Legnica
Department of Cardiology, The Copper Health Centre (MCZ)
RECRUITING
Lubin
Contact Information
Primary
Piotr Rola, MD; PhD
piotr.rola@gmail.com
+48767211446
Backup
Adrian Włodarczak, Assoc Prof.
wlodarczak.adrian@gmail.com
+48768460300
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 500
Treatments
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.
Sponsors
Leads: Regional Cardiology Center, The Copper Health Centre (MCZ),
Collaborators: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.

This content was sourced from clinicaltrials.gov