Lower Silesian Orbital Atherectomy Registry (LOAR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegional Cardiology Center, The Copper Health Centre (MCZ),
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
The presence of moderately to severely calcified lesions.
Disqualifiers
Lack of patient consent
Target vessel perforation due to previous unsuccessful lesion preparation
Pregnancy
Trial population
The study population consisted of all consecutive patients from the two cooperating cardiology departments in the Lower Silesia region with a clinical indication for PCI and the presence of severely calcified lesions who underwent percutaneous coronary intervention facilitated by an orbital atherectomy device. The decision to perform orbital atherectomy was left to the operator after detection of a moderate/severely calcified lesion.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
PCI Facilitated with Orbital Atherectomy Device
Procedure/SurgeryPercutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: OA Intervention1 intervention
Trial outcomes
Primary outcomes
1
The rate of patients who achieved The Clinical Success
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.
Time frame
Evaluation at discharge (assessed up to day 10)2
Incidence of Treatment-Emergent Adverse Events
The safety outcomes were defined as procedural complications(coronary perforation, slow- or no-reflow, new coronary thrombus, ventricular arrhythmias, vessel closure, and device failure).
Time frame
Evaluation at discharge (assessed up to day 10)Secondary outcomes
1
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE was defined as acute coronary syndrome, cerebrovascular events, major bleeding, need for repeated revascularization, or death.
Time frame
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)Sponsors and contacts
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Regional Cardiology Center, The Copper Health Centre (MCZ),
Lead sponsor
Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
Collaborator
Source ClinicalTrials.gov