Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-05-01
2027-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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OA Intervention
All consecutive patients with moderate/ severely calcified coronary lesions who underwent PCI facilitated by the Orbital Atherectomy The decision to perform orbital atherectomy was left to the operator's dissertation after the detection of a moderate/severely calcified lesion. Angiographic calcification was classified as moderate when it involved between 30% and 50% of the reference lesion diameter, and severe when it occupied over 50% of the reference diameter. When the initial assessment was based on IVUS finding lesion had to reach at least 2 points in the IVUS calcium score. There were no angiographic exclusion criteria regarding lesion anatomy such as the length, tortuosity, severity, or location. All procedural features(use additional lesion preparation technique; stent implantation parameters, periprocedural pharmacological therapy, use of intravascular imaging along with the left ventricular support device) were left to the discretion of the operator.
PCI Facilitated with Orbital Atherectomy Device
Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device
Interventions
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PCI Facilitated with Orbital Atherectomy Device
Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Target vessel perforation due to previous unsuccessful lesion preparation
* Pregnancy
18 Years
ALL
No
Sponsors
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Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
UNKNOWN
Regional Cardiology Center, The Copper Health Centre (MCZ),
OTHER
Responsible Party
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Locations
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Department of Cardiology, Provincial Specialized Hospital in Legnica
Legnica, Lower Silesian Voivodeship, Poland
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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CopperHealthCentre4
Identifier Type: -
Identifier Source: org_study_id
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