Myocardial IschaemiaCYCLOPESNCT06678594
Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification
An observational study of Myocardial Ischaemia and Severely Calcified Coronary Stenoses, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
In this study, the doctors will follow a set of rules that is called an algorithm. An algorithm is a step-by-step approach that doctors use to guide them when making decisions about the best way to treat their patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischaemia, Severely Calcified Coronary Stenoses, Coronary Calcification
- What is being tested?
- Calcium modification
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteIreland
- Study dates
- 24 Sep 2024to 23 Mar 2027
- How long will I take part?
- 1 Year
- 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: Patients with severe coronary calcification requiring calcium modification and percutaneous coronary revascularization
Who may be able to join
- Documented myocardial ischaemia.
- At least one moderate to severely calcified native coronary artery lesion confirmed by QCA and/or 60MHz HD IVUS, with the presence of significant calcium, ≥70% diameter stenosis by visual estimation (in a reference vessel diameter of ≥2.5mm and ≤4.0mm) and TIMI 3 flow at baseline that is suitable for PCI.
- Significant calcium at the target lesion site is defined as either: i. The presence of radiopacities involving both sides of the arterial wall \>10mm and involving the target lesion on angiography.
- or ii. The presence of \>270° arc of superficial calcium on HD intravascular imaging with a length \>5mm or the presence of 360° arc of calcium on HD intravascular imaging. [1]
- It is possible to cross the calcified lesion with a coronary guidewire.
- Age ≥ 18 years.
- Patient is willing and able to comply with the study procedures and follow-up.
Who cannot join
- Patients with cardiogenic shock.
- ST-segment elevation myocardial infarction.
- Instent re-stenosis.
- Stent thrombosis.
- Coronary artery dissection.
- Chronic total occlusion in a major artery.
- Left ventricular ejection fraction ≤30%. Need for coronary artery bypass graft surgery.
- 9. Documented allergy to everolimus or to any stent material 10. Any contraindication for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for at least 3 months (except for patients on oral anticoagulation). 11. For female, pregnancy, breastfeeding or intend to become pregnant within 1 year 12. Life expectancy \<1 year. 13. Participation in another study with an investigational product. 14. Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Mater Private Hospital
Dublin
Colm Hanratty, 0035312481820, cvri@materprivate.ie
Carmen Farrelly, 0035312481820, carmen.farrelly@materprivate.ie
About this study
Official title: Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES)
In this study, the doctors will follow a set of rules that is called an algorithm. An algorithm is a step-by-step approach that doctors use to guide them when making decisions about the best way to treat their patients. Algorithms are useful because they help doctors decide on the best treatment approach based on the patient's individual circumstances and the best medical evidence available. The algorithm that is being used in this study is called a calcium modification algorithm and it will guide doctors when deciding on the best way to modify or break up the calcium in coronary arteries.
In this study, we aim to prove that the calcium modification algorithm, described above, safely and effectively guides doctors on the best way to modify calcium in patients' coronary arteries. By doing so, it will help doctors in making decisions about patients' treatment during their procedure. It will also help standardise care for patients, so patients receive the same treatment no matter what hospital they are in or what doctor is treating them.
Read the detailed description
Investigational strategy:
Calcium modification algorithm to guide coronary intervention with an High Definition Intra Vascular Ultrasound (HD IVUS) imaging guided pathway that provides a systematic approach to coronary modification.
Objectives:
The aim of this study is to validate a comprehensive and intravascular imaging-based calcium modification algorithm for the treatment of moderate to severely calcified coronary lesions.
Study Population:
Patients with coronary artery disease with evidence of moderate to severely calcified coronary arterial lesions that are planned for percutaneous intervention requiring calcium modification.
Design:
CYCLOPES is a prospective, multicenter, open-label, single arm trial assessing the feasibility and efficacy of an intracoronary ultrasound guided algorithm for calcium modification in patients undergoing percutaneous coronary intervention (PCI) for chronic calcific coronary artery disease. The study will enrol 500 patients who will undergo PCI with calcium modification.
Participants will be enrolled prospectively in 25 sites in Ireland, Switzerland, the United Kingdom, Spain, France, Italy and Germany (7 countries).
All patients will have coronary angiography (QCA) and intravascular ultrasound (IVUS) imaging with 60MHz HD IVUS of the calcified lesion at baseline. The lesion will be characterized based on calcium distribution and morphology as assessed by HD IVUS. Depending on the specific lesion characteristics, the appropriate method for calcium modification will be chosen and performed in line with the CYCLOPES calcium modification algorithm included in the study protocol.
The calcific lesion will be imaged for a second time by 60MHz HD IVUS following calcium modification. The operator will then proceed, if no further lesion preparation is required, to deploy a bioabsorbable polymer Everolimus eluting stent using standard stenting techniques, post dilatation will be performed at the operator's discretion. The treated lesion will be assessed again using intravascular ultrasound following stent deployment and optimization.
The primary end points will be the post stenting minimal stent area (MSA) at the site of maximum calcification relative to reference lumen area assessed with 60MHz HD IVUS and target lesion failure (TLF) at 1-year post-procedure. All HD IVUS determined endpoints will be assessed at an independent imaging core laboratory.
Participants will be assessed with clinic or phone visits at hospital discharge, 1 month and 12-month time points post procedure.
- Being tested
- Calcium modification
- Keywords
- calcium modification, coronary calcification, plaque modification, IVUS, Intravascular Ultrasound, calcium modification algorithm
- 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.
Calcium modificationProcedure or surgery
Also called plaque modification
Patients will undergo one or more of the following procedures, subject to the algorithm:
Angioplasty Balloon Cutting Balloon Rotational Atherectomy Intravascular Lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| Patient treatment will follow a standardised algorithm for calcium modification | All patients will have coronary angiography (QCA) and intravascular ultrasound (IVUS) imaging with 60MHz HD IVUS of the calcified lesion at baseline. The lesion will be characterized based on calcium distribution and morphology as assessed by HD IVUS. Depending on the specific lesion characteristics, the appropriate method for calcium modification will be chosen and performed in line with the CYCLOPES calcium modification algorithm included in the study protocol.
The calcific lesion will be imaged for a second time by 60MHz HD IVUS following calcium modification. The operator will then proceed, if no further lesion preparation is required, to deploy a bioabsorbable polymer Everolimus eluting stent using standard stenting techniques, post dilatation will be performed at the operator's discretion. The treated lesion will be assessed again using intravascular ultrasound following stent deployment and optimization. Receives: Procedure: Calcium modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum stent area (MSA)
Minimum stent area (MSA) at the site of maximum calcification measured at the end of the index procedure
Measured: End of Index Procedure
Target lesion failure (TLF)
Target lesion failure (TLF) (cardiovascular death, non-fatal myocardial infarction (MI) related to the target vessel, unplanned ischemia-driven target lesion revascularization) at 1 year
Measured: At Year 1
Secondary outcomes (8)
Individual components of TLF at 1 month and 1 year
Individual components of TLF at 1 month and 1 year
Measured: At 1 month and 1 year
Minimum stent area (MSA) at the end of the index procedure
Minimum stent area (MSA) at the end of the index procedure
Measured: At end of index procedure
Strategy Success
Strategy success defined as:
- Successful stent delivery
- ≥ 80% stent expansion
- Complete stent apposition
- No edge dissection
- Full lesion coverage with \<50% plaque burden at proximal and distal references
- TIMI 3 flow
Measured: At end of index procedure
Target vessel revascularization (TVR)
Target vessel revascularization (TVR)
Measured: At Year 1
Target lesion revascularization (TLR)
Target lesion revascularization (TLR)
Measured: At Year 1
Stent thrombosis
Stent thrombosis
Measured: At Year 1
Stroke
Stroke
Measured: At Year 1
Cardiovascular death
Cardiovascular death
Measured: At Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start24 Sep 2024
- Primary completion23 Mar 2026 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschaemiaStudies 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
- 1 Year
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiovascular Research Institute Dublin
- Responsible party
- Sponsor
- Investigators
- Robert A Byrne, Principal investigator, RCSI University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678594
- Sponsor's protocol ID
- CYCLOPES V1.1
- Acronym
- CYCLOPES
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, the study team plan to make anonymized study data available to members of the research community, both academic and industry, who request access to it. This is called open access to clinical trial data and the aim is to help other researchers and encourage transparency in clinical research by allowing other researchers 'test' the findings from this study and develop tools to help treatment of other patients in the future. Personal data will not be shared with anyone outside of those listed in the Patient Information Leaflet (ie Hospital Study Team, Members of committee monitoring the safety of the trial, sponsor auditor \& regulatory authorities etc. It will not be possible to identify an individual as the data shared will be anonymized data, for example in addition to personal data being replaced by coding, date of birth with be changed to a date range (e.g. 35-44 yrs old) to ensure that patients cannot be identified from the data shared.
Publications
O'Callaghan D, Durand R, Hanratty CG, Cuisset T, Vaquerizo B, Sinning JM, O'Kane P, Coughlan JJ, Walsh S, Colleran R, Rai H, Soliman O, Barbato E, Stahli BE, Byrne RA. A Prospective, Multicenter, Open Label Study Investigating the Implementation of a Standardized Algorithm for Coronary CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES): Design and Rationale of the CYCLOPES Trial. Catheter Cardiovasc Interv. 2026 Mar;107(4):1018-1026. doi: 10.1002/ccd.70424. Epub 2025 Dec 17.
PubMed 41408534
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES)
- ClinicalTrials.gov ID
- NCT06678594
- Acronym / sponsor ID
- CYCLOPES / CYCLOPES V1.1
- Keywords
- calcium modification, coronary calcification, plaque modification, IVUS, Intravascular Ultrasound, calcium modification algorithm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Cardiovascular Research Institute Dublin
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 23 Mar 2026 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 7 Nov 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.
In this study, the doctors will follow a set of rules that is called an algorithm. An algorithm is a step-by-step approach that doctors use to guide them when making decisions about the best way to treat their patients. Algorithms are useful because they help doctors decide on the best treatment approach based on the patient's individual circumstances and the best medical evidence available. The algorithm that is being used in this study is called a calcium modification algorithm and it will guide doctors when deciding on the best way to modify or break up the calcium in coronary arteries.
In this study, we aim to prove that the calcium modification algorithm, described above, safely and effectively guides doctors on the best way to modify calcium in patients' coronary arteries. By doing so, it will help doctors in making decisions about patients' treatment during their procedure. It will also help standardise care for patients, so patients receive the same treatment no matter what hospital they are in or what doctor is treating them.
Detailed description
Investigational strategy:
Calcium modification algorithm to guide coronary intervention with an High Definition Intra Vascular Ultrasound (HD IVUS) imaging guided pathway that provides a systematic approach to coronary modification.
Objectives:
The aim of this study is to validate a comprehensive and intravascular imaging-based calcium modification algorithm for the treatment of moderate to severely calcified coronary lesions.
Study Population:
Patients with coronary artery disease with evidence of moderate to severely calcified coronary arterial lesions that are planned for percutaneous intervention requiring calcium modification.
Design:
CYCLOPES is a prospective, multicenter, open-label, single arm trial assessing the feasibility and efficacy of an intracoronary ultrasound guided algorithm for calcium modification in patients undergoing percutaneous coronary intervention (PCI) for chronic calcific coronary artery disease. The study will enrol 500 patients who will undergo PCI with calcium modification.
Participants will be enrolled prospectively in 25 sites in Ireland, Switzerland, the United Kingdom, Spain, France, Italy and Germany (7 countries).
All patients will have coronary angiography (QCA) and intravascular ultrasound (IVUS) imaging with 60MHz HD IVUS of the calcified lesion at baseline. The lesion will be characterized based on calcium distribution and morphology as assessed by HD IVUS. Depending on the specific lesion characteristics, the appropriate method for calcium modification will be chosen and performed in line with the CYCLOPES calcium modification algorithm included in the study protocol.
The calcific lesion will be imaged for a second time by 60MHz HD IVUS following calcium modification. The operator will then proceed, if no further lesion preparation is required, to deploy a bioabsorbable polymer Everolimus eluting stent using standard stenting techniques, post dilatation will be performed at the operator's discretion. The treated lesion will be assessed again using intravascular ultrasound following stent deployment and optimization.
The primary end points will be the post stenting minimal stent area (MSA) at the site of maximum calcification relative to reference lumen area assessed with 60MHz HD IVUS and target lesion failure (TLF) at 1-year post-procedure. All HD IVUS determined endpoints will be assessed at an independent imaging core laboratory.
Participants will be assessed with clinic or phone visits at hospital discharge, 1 month and 12-month time points post procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treatment will follow a standardised algorithm for calcium modification | – | Procedure: Calcium modificationAll patients will have coronary angiography (QCA) and intravascular ultrasound (IVUS) imaging with 60MHz HD IVUS of the calcified lesion at baseline. The lesion will be characterized based on calcium distribution and morphology as assessed by HD IVUS. Depending on the specific lesion characteristics, the appropriate method for calcium modification will be chosen and performed in line with the CYCLOPES calcium modification algorithm included in the study protocol. The calcific lesion will be imaged for a second time by 60MHz HD IVUS following calcium modification. The operator will then proceed, if no further lesion preparation is required, to deploy a bioabsorbable polymer Everolimus eluting stent using standard stenting techniques, post dilatation will be performed at the operator's discretion. The treated lesion will be assessed again using intravascular ultrasound following stent deployment and optimization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe coronary calcification requiring calcium modification and percutaneous coronary revascularization
Key inclusion criteria (7 listed)
- Documented myocardial ischaemia.
- At least one moderate to severely calcified native coronary artery lesion confirmed by QCA and/or 60MHz HD IVUS, with the presence of significant calcium, ≥70% diameter stenosis by visual estimation (in a reference vessel diameter of ≥2.5mm and ≤4.0mm) and TIMI 3 flow at baseline that is suitable for PCI.
- or ii. The presence of \>270° arc of superficial calcium on HD intravascular imaging with a length \>5mm or the presence of 360° arc of calcium on HD intravascular imaging. [1]
- It is possible to cross the calcified lesion with a coronary guidewire.
- Age ≥ 18 years.
Key exclusion criteria (8 listed)
- Patients with cardiogenic shock.
- ST-segment elevation myocardial infarction.
- Instent re-stenosis.
- Stent thrombosis.
- Coronary artery dissection.
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 |
|---|---|---|
| Calcium modificationAlso: plaque modificationPatients will undergo one or more of the following procedures, subject to the algorithm: Angioplasty Balloon Cutting Balloon Rotational Atherectomy Intravascular Lithotripsy | Procedure or surgery | Patient treatment will follow a standardised algorithm for calcium modification |
Primary outcome
Minimum stent area (MSA)
Time frame: End of Index Procedure
Minimum stent area (MSA) at the site of maximum calcification measured at the end of the index procedure
Target lesion failure (TLF)
Time frame: At Year 1
Target lesion failure (TLF) (cardiovascular death, non-fatal myocardial infarction (MI) related to the target vessel, unplanned ischemia-driven target lesion revascularization) at 1 year
8 secondary outcomes
Individual components of TLF at 1 month and 1 year
Time frame: At 1 month and 1 year
Minimum stent area (MSA) at the end of the index procedure
Time frame: At end of index procedure
Strategy Success
Time frame: At end of index procedure
Target vessel revascularization (TVR)
Time frame: At Year 1
Target lesion revascularization (TLR)
Time frame: At Year 1
Stent thrombosis
Time frame: At Year 1
Stroke
Time frame: At Year 1
Cardiovascular death
Time frame: At Year 1
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 7 Nov 2024.
- Derived from this study: PubMed 41408534O'Callaghan D, Durand R, Hanratty CG, Cuisset T, Vaquerizo B, Sinning JM, O'Kane P, Coughlan JJ, Walsh S, Colleran R, Rai H, Soliman O, Barbato E, Stahli BE, Byrne RA. A Prospective, Multicenter, Open Label Study Investigating the Implementation of a Standardized Algorithm for Coronary CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES): Design and Rationale of the CYCLOPES Trial. Catheter Cardiovasc Interv. 2026 Mar;107(4):1018-1026. doi: 10.1002/ccd.70424. Epub 2025 Dec 17.
- Individual participant dataSharing planned: Yes. At the end of the study, the study team plan to make anonymized study data available to members of the research community, both academic and industry, who request access to it. This is called open access to clinical trial data and the aim is to help other researchers and encourage transparency in clinical research by allowing other researchers 'test' the findings from this study and develop tools to help treatment of other patients in the future. Personal data will not be shared with anyone outside of those listed in the Patient Information Leaflet (ie Hospital Study Team, Members of committee monitoring the safety of the trial, sponsor auditor \& regulatory authorities etc. It will not be possible to identify an individual as the data shared will be anonymized data, for example in addition to personal data being replaced by coding, date of birth with be changed to a date range (e.g. 35-44 yrs old) to ensure that patients cannot be identified from the data shared.
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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.
Robert A Byrne principal investigator
RCSI University of Medicine and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischaemia and Severely Calcified Coronary Stenoses, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 7 inclusion and 8 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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 Robert A Byrne (00353858802094, robert.byrne@materprivate.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum stent area (MSA) (time frame: End of Index Procedure). 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 NCT06678594, which also lists 1 linked publication.
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 7 Nov 2024.