NCT06451146

Lower Silesian Orbital Atherectomy Registry (LOAR)

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
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ), · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study population consisted of all consecutive patients with severely calcified coronary lesions undergoing percutaneous coronary intervention (PCI) with the Orbital Atherectomy Device at two cooperating cardiac centers (Department of Cardiology, The Copper Health Center, Lubin, Poland, and Department of Cardiology, Provincial Specialized Hospital in Legnica, Poland). All study patients had a clinical indication for PCI based on current European Society of Cardiology (ESC) revascularization guidelines, with local heart team support where appropriate. The decision to perform OA-assisted PCI was left to the discretion of the operator, based on clinical and angiographic features with a concomitant assessment of calcification. Only patients with moderate or severe calcification were enrolled. Calcification severity was defined either by angiographic assessment or by intravascular assessment using intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT). All patients were thoroughly informed about all therapeutic options and PCI-related risks before giving written consent.

Conditions

• Safety Issues
• Efficacy, Self

Interventions

Type	Name	Description
PROCEDURE	PCI Facilitated with Orbital Atherectomy Device	Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device

Timeline

• Start date: 2022-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2024-06-11
• Last updated: 2024-08-21

Locations

2 sites across 1 country: Poland