Introduction of a standardized method for the treatment of calcifications in coronary arteries with ultrasound support to improve treatment outcomes
Zusammenfassung der Studie
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)
Untersuchte Intervention
Treatment algorithm as a systematic approach to calcification modification in the treatment of coronary artery disease with moderately to severely calcified lesions
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
St Gallen, Zürich
(BASEC)
Sponsor
Royal College of Surgeons in Ireland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Ravi Kumar Khetavat
+33 06 60 05 54 68
rkhetavat@cluttercerc-europe.orgCardiovascular European Research Center
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
25.04.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn with PlaquE Modification using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES) (BASEC)
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