Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06451146
Other study ID # CopperHealthCentre4
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT04485481 - Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers Phase 1
Completed NCT03473236 - Phase 1A Safety Trial of Inhaled PK10571 (GB002) Phase 1
Not yet recruiting NCT03683953 - The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells Phase 1
Recruiting NCT05546567 - NOPARK Open Label Extension Study N/A
Recruiting NCT05413226 - Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility N/A
Recruiting NCT05112159 - Study of IPG1094 in Healthy Participants Phase 1
Completed NCT04689035 - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144 Phase 1
Completed NCT04335045 - Phase I Study of PH100 (Ecklonia Cava Phlorotannins) Phase 1
Completed NCT05037227 - Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Recruiting NCT05517291 - DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease N/A
Enrolling by invitation NCT06446778 - Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Completed NCT04188821 - Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander N/A
Completed NCT03667430 - Safety Evaluation of Porous Silica in Men N/A
Completed NCT04499482 - Safety and Tolerability of Soy Fiber N/A
Completed NCT03141905 - Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease N/A
Completed NCT05244161 - A Quasi-experimental Evaluation of the Malezi Program in Tanzania N/A
Recruiting NCT03791372 - Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy Phase 1
Withdrawn NCT04759066 - The HEALiX™ Intubated Patient (IP) Pilot Study N/A