Lower Silesian Orbital Atherectomy Registry (LOAR)

Recruiting

• Conditions: Efficacy, Self; Safety Issues

• Registration Number: NCT06451146
• Lead Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ),

Brief 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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-06-08
• Study First Posted: 2024-06-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Evaluation at discharge (assessed up to day 10)	The safety outcomes were defined as procedural complications(coronary perforation, slow- or no-reflow, new coronary thrombus, ventricular arrhythmias, vessel closure, and device failure).
The rate of patients who achieved The Clinical Success	Evaluation at discharge (assessed up to day 10)	Clinical success was defined as effective stent deployment without significant stent under expansion and the presence of Thrombolysis in Myocardial Infarction (TIMI) 3 flow at the end of the procedure.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	Final assessment - 5 years after the initial hospitalization; followed by evaluation every 6 months from the end of the hospitalization until the final assessment (5 years)	MACCE was defined as acute coronary syndrome, cerebrovascular events, major bleeding, need for repeated revascularization, or death.

Trial Locations

Locations (2)

Department of Cardiology, Provincial Specialized Hospital in Legnica; 🇵🇱 Legnica, Lower Silesia, Poland

Department of Cardiology, The Copper Health Centre (MCZ); 🇵🇱 Lubin, Lower Silesia, Poland