NCT06451146

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2022May 2027

Study Start

First participant enrolled

May 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

March 3, 2024

Last Update Submit

August 19, 2024

Conditions

Safety IssuesEfficacy, Self

Keywords

Percutaneous coronary interventionsCalcified LesionCoronary artery diseasesOrbital AtherectomyLesion preparation

Outcome Measures

Primary Outcomes (2)

  • The rate of patients who achieved 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)

  • 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 Outcomes (1)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    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)

Study Arms (1)

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.

Procedure: PCI Facilitated with Orbital Atherectomy Device

Interventions

PCI Facilitated with Orbital Atherectomy DevicePROCEDURE

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

OA Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • The presence of moderately to severely calcified lesions.

You may not qualify if:

  • Lack of patient consent
  • Target vessel perforation due to previous unsuccessful lesion preparation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiology, Provincial Specialized Hospital in Legnica

Legnica, Lower Silesian Voivodeship, 59-220, Poland

RECRUITING

Department of Cardiology, The Copper Health Centre (MCZ)

Lubin, Lower Silesian Voivodeship, 59-300, Poland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 37373718RESULT

  • 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.

    PMID: 36594531RESULT

  • 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.

    PMID: 37762782RESULT

  • 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.

    PMID: 36573605RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Piotr Rola, MD; PhD

CONTACT

+48767211446piotr.rola@gmail.com

Adrian Włodarczak, Assoc Prof.

CONTACT

+48768460300wlodarczak.adrian@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2024

First Posted

June 11, 2024

Study Start

May 1, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)