Introduction of a standardized method for the treatment of calcifications in coronary arteries with ultrasound support to improve treatment outcomes
Summary description of the study
CYCLOPES is an open study with only one treatment group. It examines whether a specific predefined protocol (algorithm) for calcification, which works using ultrasound images from blood vessels (IVUS), is effective and feasible in practice for patients with moderately to severely calcified coronary arteries requiring minimally invasive vessel dilation (PTCA). The study will be conducted at a total of 25 hospitals in Switzerland, Germany, France, Ireland, Spain, and the United Kingdom. A total of 500 patients are to be included in the study. All participants will first undergo examination of the coronary arteries using X-ray (coronary angiography). This will then be supplemented by IVUS to examine the calcified areas more closely. The calcifications will be assessed based on their distribution and shape. Based on these characteristics, the appropriate method for calcification treatment according to the CYCLOPES algorithm will be selected and performed using specific devices regularly used in routine treatment. Afterward, the lesion will be re-examined using IVUS. Subsequently, a drug-eluting stent will be placed using standard techniques, with post-dilation at the discretion of the treating physician. After stent placement, the treated lesion will be examined again with IVUS to optimize the results. The primary endpoints of the study are the minimal stent area compared to the reference lumen area (assessed by IVUS) after stent placement, as well as major cardiovascular events recorded one year after the procedure. All endpoints determined by intravascular ultrasound will be verified in an independent imaging laboratory. Study participants will be followed up after their discharge from the hospital, as well as one month and twelve months after the procedure, either in the clinic or by phone.
(BASEC)
Intervention under investigation
Treatment algorithm as a systematic approach to calcification modification in the treatment of coronary artery disease with moderately to severely calcified lesions
(BASEC)
Disease under investigation
coronary artery disease with moderate or severe calcification
(BASEC)
1. Documented ischemic heart disease 2. Presence of at least one severely narrowed (at least 70%) coronary artery with moderate to severe calcification, which has been demonstrated by medical imaging (e.g., X-ray or intravascular ultrasound). The coronary artery is suitable for treatment by Percutaneous Transluminal Coronary Angioplasty (PTCA). Moderate to severe calcification is present if: • calcifications are visible on the X-ray on both sides of the arterial wall over more than 1 cm, or. • during an intravascular ultrasound examination (IVUS), calcification is found in a large arc (>270°) over more than 5 mm or circumferentially (360°). 3. It is possible to pass the calcified area in the coronary artery with a guide wire. 4. Participants must be at least 18 years old. 5. The patient is willing and able to comply with the study procedures and follow-up examinations. (BASEC)
Exclusion criteria
1. Patients with cardiogenic shock or severe heart attack (ST-elevation myocardial infarction) 2. Stenosis (restenosis) or blood clot (thrombosis) in an already placed stent 3. Tear in the wall of a coronary artery or permanent total occlusion of a major artery of the heart 4. Need for bypass surgery on the coronary arteries 5. In women: pregnancy, breastfeeding, or plans to become pregnant within one year. 6. Presence of reasons that contraindicate the simultaneous use of two platelet aggregation inhibitors – aspirin and a P2Y12 inhibitor – for at least 3 months (except for patients already taking oral anticoagulants). (BASEC)
Trial sites
St. Gallen, Zurich
(BASEC)
Sponsor
Royal College of Surgeons in Ireland
(BASEC)
Contact
Contact Person Switzerland
Ravi Kumar Khetavat
+33 06 60 05 54 68
rkhetavat@cluttercerc-europe.orgCardiovascular European Research Center
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
25.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn with PlaquE Modification using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES) (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
not available
Link to the results in the primary register
not available