Clinical trial NCT06451146: Lower Silesian Orbital Atherectomy Registry (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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Safety Issues
Efficacy, Self
Keywords: Percutaneous coronary interventions
Calcified Lesion
Coronary artery diseases
Orbital Atherectomy
Lesion preparation
Lead sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ),
Sponsor class: OTHER
Collaborators: name: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
First posted: 2024-06-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of patients who achieved The Clinical Success
timeFrame: Evaluation at discharge (assessed up to day 10)
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Evaluation at discharge (assessed up to day 10)
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 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)
Other outcomes:
Locations:
city: Legnica
country: Poland
facility: Department of Cardiology, Provincial Specialized Hospital in Legnica
state: Lower Silesia
city: Lubin
country: Poland
facility: Department of Cardiology, The Copper Health Centre (MCZ)
state: Lower Silesia
Study officials:
References:
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 13;12(12):4025. doi: 10.3390/jcm12124025.
citation: 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 outcomes of the Lower-Silesia Orbital Atherectomy Registry (LOAR). Kardiol Pol. 2023;81(2):174-176. doi: 10.33963/KP.a2023.0003. Epub 2023 Jan 3. No abstract available.
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). J Clin Med. 2023 Sep 8;12(18):5842. doi: 10.3390/jcm12185842.
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 intervention in heavily calcified coronary lesions. Kardiol Pol. 2023;81(3):296-297. doi: 10.33963/KP.a2023.0005. Epub 2022 Dec 27. No abstract available.