Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451146
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-03-03
Brief Title:
Lower Silesian Orbital Atherectomy Registry LOAR
Sponsor:
Regional Cardiology Center The Copper Health Centre MCZ
Organization:
Regional Cardiology Center The Copper Health Centre MCZ
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOAR
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 andor optical coherence tomography OCT All patients were thoroughly informed about all therapeutic options and PCI-related risks before giving written consent
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 andor optical coherence tomography OCT All patients were thoroughly informed about all therapeutic options and PCI-related risks before giving written consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None