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NCT Number: NCT06451146

Lower Silesian Orbital Atherectomy Registry (LOAR)

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).

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Key information

Conditions

Safety Issues Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Efficacy, Self Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, Provincial Specialized Hospital in Legnica, Legnica, Lower Silesian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI Facilitated with Orbital Atherectomy Device

Procedure

Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device

Primary outcomes

  1. The rate of patients who achieved The Clinical Success

    Time frame: 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.

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: 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 outcomes

  1. Major adverse cardiac and cerebrovascular events (MACCE)

    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)

    MACCE was defined as acute coronary syndrome, cerebrovascular events, major bleeding, need for repeated revascularization, or death.

Study contacts

Contact information is provided by the study sponsor or research team.

Adrian Włodarczak, Assoc Prof.

CONTACT

[email protected]

+48768460300

Piotr Rola, MD; PhD

CONTACT

[email protected]

+48767211446

Sponsors and collaborators

Lead sponsor

Regional Cardiology Center, The Copper Health Centre (MCZ),

Other

Collaborators

  • Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.

Registry information

Official study 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)

Acronym: LOAR

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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