Efficacy, Self, Safety Issues
Conditions
Keywords
Percutaneous coronary interventions, Calcified Lesion, Coronary artery diseases, Orbital Atherectomy, Lesion preparation
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.
Interventions
PROCEDUREPCI Facilitated with Orbital Atherectomy Device
Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device
Sponsors
Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
Regional Cardiology Center, The Copper Health Centre (MCZ),
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Contacts
Primary ContactPiotr Rola, MD; PhD
Backup ContactAdrian Włodarczak, Assoc Prof.
Outcome results
None listed