Lower Silesian Orbital Atherectomy Registry (LOAR)

Safety Issues Clinical Trial

— LOAR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451146
• Other study ID #: CopperHealthCentre4
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 1, 2027

Study information

• Verified date: June 2024
• Source: Regional Cardiology Center, The Copper Health Centre (MCZ),
• Contact: Piotr Rola, MD; PhD
• Phone: +48767211446
• Email: piotr.rola[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Efficacy, Self
• Safety Issues

Intervention

Procedure:
• PCI Facilitated with Orbital Atherectomy Device
Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device

Locations

Country	Name	City	State
Poland	Department of Cardiology, Provincial Specialized Hospital in Legnica	Legnica	Lower Silesia
Poland	Department of Cardiology, The Copper Health Centre (MCZ)	Lubin	Lower Silesia

Sponsors (2)

Lead Sponsor	Collaborator
Regional Cardiology Center, The Copper Health Centre (MCZ),	Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Rola P, Furtan L, Wlodarczak S, Jastrzebski A, Barycki M, Kedzierska M, Szudrowicz M, Kulczycki JJ, Doroszko A, Lesiak M, Wlodarczak A. Orbital atherectomy for treatment of calcified coronary artery lesions. First experiences in Poland: Short-term outcome — View Citation

Rola P, Kulczycki JJ, Barycki M, Wlodarczak S, Furtan L, Kedzierska M, Giniewicz K, Doroszko A, Lesiak M, Wlodarczak A. Comparison of Orbital Atherectomy and Rotational Atherectomy in Calcified Left Main Disease: Short-Term Outcomes. J Clin Med. 2023 Jun — View Citation

Rola P, Wlodarczak S, Barycki M, Furtan L, Jastrzebski A, Kedzierska M, Doroszko A, Lesiak M, Wlodarczak A. Safety and Efficacy of Orbital Atherectomy in the All-Comer Population: Mid-Term Results of the Lower Silesian Orbital Atherectomy Registry (LOAR). — View Citation

Wlodarczak S, Rola P, Furtan L, Barycki M, Szudrowicz M, Kulczycki JJ, Doroszko A, Lesiak M, Wlodarczak A. Orbital-Tripsy - orbital atherectomy facilitated by Shockwave Intravascular Lithotripsy: Novel bailout strategy in percutaneous coronary interventio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluation at discharge (assessed up to day 10)
Primary	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).	Evaluation at discharge (assessed up to day 10)
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	MACCE was defined as acute coronary syndrome, cerebrovascular events, major bleeding, need for repeated revascularization, or death.	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)