Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification

NCT06678594 | Recruiting DMC

• 1 other identifier: CYCLOPES V1.1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Ischaemia; Severely Calcified Coronary Stenoses; Coronary Calcification

Keywords

calcium modification; coronary calcification; plaque modification; IVUS; Intravascular Ultrasound; calcium modification algorithm

Outcome Measures

Primary Outcomes (2)

• Minimum stent area (MSA)

  Minimum stent area (MSA) at the site of maximum calcification measured at the end of the index procedure

  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

  At Year 1

Secondary Outcomes (8)

• Individual components of TLF at 1 month and 1 year

  At 1 month and 1 year

• Minimum stent area (MSA) at the end of the index procedure

  At end of index procedure

• Strategy Success

  At end of index procedure

• Target vessel revascularization (TVR)

  At Year 1

• Target lesion revascularization (TLR)

  At Year 1

Study Arms (1)

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.

Procedure: Calcium modification

Interventions

Calcium modification PROCEDURE

Patients will undergo one or more of the following procedures, subject to the algorithm: Angioplasty Balloon Cutting Balloon Rotational Atherectomy Intravascular Lithotripsy

Also known as: plaque modification

Patient treatment will follow a standardised algorithm for calcium modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe coronary calcification requiring calcium modification and percutaneous coronary revascularization

You may qualify if:

• 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.
• a. 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.

You may not qualify if:

• 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.
• \. 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Cardiovascular Research Institute Dublin: collaborator

Study Sites (1)

Mater Private Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

• 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. 2025 Dec 17. doi: 10.1002/ccd.70424. Online ahead of print.

  PMID: 41408534 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert A Byrne

  RCSI University of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert A Byrne

CONTACT

00353858802094; robert.byrne@materprivate.ie

Amy Carswell

CONTACT

00353858802094; amy.carswell@materprivate.ie

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: September 24, 2024
• Primary Completion: March 23, 2026
• Study Completion (Estimated): March 23, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

IE (1)