Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Minimum stent area (MSA)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Any contraindication for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for at least 3 months (except for patients on oral anticoagulation).
- •For female, pregnancy, breastfeeding or intend to become pregnant within 1 year
- •Life expectancy <1 year.
- •Participation in another study with an investigational product.
- •Inability to provide informed consent.
结局指标
主要结局
Minimum stent area (MSA)
时间窗: 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)
时间窗: 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
次要结局
- Stent thrombosis(At Year 1)
- 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)
- Stroke(At Year 1)
- Cardiovascular death(At Year 1)