Safety IssuesLOARNCT06451146
Lower Silesian Orbital Atherectomy Registry (LOAR)
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- PCI Facilitated with Orbital Atherectomy Device
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesPoland
- Study dates
- 1 May 2022to 1 May 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The presence of moderately to severely calcified lesions.
Who cannot join
- Lack of patient consent
- Target vessel perforation due to previous unsuccessful lesion preparation
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Provincial Specialized Hospital in Legnica
Legnica, Lower Silesian Voivodeship, 59-220
Piotr Rola, M.D; PhD, +48767211446, piotr.rola@gmail.com
Lukasz Furtan, MD, +48767211446, lukas.furtan@gmail.com
- Recruiting
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, 59-300
Adrian Włodarczak, Assoc Prof., +48768460300, wlodarczak.adrian@gmail.com
Szymon Włodarczak, M.D., +48768460300, wlodarczak.szy@gmail.com
About this study
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)
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).
Read the 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.
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- PCI Facilitated with Orbital Atherectomy Device
- Keywords
- Percutaneous coronary interventions, Calcified Lesion, Coronary artery diseases, Orbital Atherectomy, Lesion preparation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI Facilitated with Orbital Atherectomy DeviceProcedure or surgery
Percutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PCI Facilitated with Orbital Atherectomy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Evaluation at discharge (assessed up to day 10)
Secondary outcomes (1)
Major adverse cardiac and cerebrovascular events (MACCE)
MACCE was defined as acute coronary syndrome, cerebrovascular events, major bleeding, need for repeated revascularization, or death.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 May 2022
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Miedziowe Centrum Zdrowia SA
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451146
- Sponsor's protocol ID
- CopperHealthCentre4
- Acronym
- LOAR
- Status last verified
- Aug 2024
- First submitted
- 3 Mar 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37373718Rola 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.
PubMed 36594531Rola 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.
PubMed 37762782Wlodarczak 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.
PubMed 36573605
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06451146
- Acronym / sponsor ID
- LOAR / CopperHealthCentre4
- Conditions
- Safety Issues, Efficacy, Self
- Keywords
- Percutaneous coronary interventions, Calcified Lesion, Coronary artery diseases, Orbital Atherectomy, Lesion preparation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Miedziowe Centrum Zdrowia SAUniversity, hospital or other
- Collaborators
- Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland.
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OA Intervention | – | Procedure: PCI Facilitated with Orbital Atherectomy DeviceAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The presence of moderately to severely calcified lesions.
Key exclusion criteria (3 listed)
- Lack of patient consent
- Target vessel perforation due to previous unsuccessful lesion preparation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI Facilitated with Orbital Atherectomy DevicePercutaneous coronary intervention for coronary artery disease supported by the Orbital Atherectomy Device | Procedure or surgery | OA Intervention |
Primary outcome
The rate of patients who achieved The Clinical Success
Time frame: Evaluation at discharge (assessed up to day 10)
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.
Incidence of Treatment-Emergent Adverse Events
Time frame: Evaluation at discharge (assessed up to day 10)
The safety outcomes were defined as procedural complications(coronary perforation, slow- or no-reflow, new coronary thrombus, ventricular arrhythmias, vessel closure, and device failure).
1 secondary outcome
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 37373718Rola 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.
- Results publication: PubMed 36594531Rola 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.
- Results publication: PubMed 37762782Rola 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.
- Results publication: PubMed 36573605Wlodarczak 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.
- Individual participant dataSharing planned: No
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues and Efficacy, Self, run by Miedziowe Centrum Zdrowia SA at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Rola, MD; PhD (+48767211446, piotr.rola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients who achieved The Clinical Success (time frame: Evaluation at discharge (assessed up to day 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451146, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.