NCT04591938招募中不适用
Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study
Joost Daemen3 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2019年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Device-Oriented Composite Endpoint (DOCE)
研究概览
简要总结
Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).
详细描述
Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium.
Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •18 years or older
- •Stable angina, unstable angina or documented silent ischemia (invasive or non-invasive test) or non-ST segment elevation acute myocardial infarction.
- •De-novo non-complex coronary obstructive lesions (>50% stenosis as assessed by quantitative coronary analysis (QCA))
- •The patient is willing and able to comply with the specified follow-up evaluations.
- •Reference vessel diameter (RVD) ≥ 2.5 mm and ≤ 4.0 mm by QCA.
- •During pre-dilatation, the pre-dilatation balloon is uniformly expanded to the full intended diameter.
- •Target segment suitable for OCT imaging
排除标准
- •Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow 0 or
- •Target lesion located within 5.0 mm of vessel origin.
- •Lesion type ACC/AHA C.
- •Heavily calcified lesion
- •Severe tortuosity
- •Target lesion is located in or supplied by an arterial or venous bypass graft.
- •Target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
- •Unsuccessful pre-dilatation, defined as a residual diameter stenosis ≥ 30%, assessed by QCA.
- •Planned future revascularization of non-culprit lesions.
- •Presence of another device (stent or scaffold) located within the same segment (5mm from the target lesion borders).
- •Patient is currently participating in another study with an investigational device or an investigational drug and has not completed the entire follow-up period.
- •Impaired renal function (eGFR <30ml/min).
- •Patient has a contraindication for the use of double antiplatelet therapy for at least 12 months.
- •Pregnant or breastfeeding patients.
- •Patient has a known allergy to contrast medium, sirolimus, Tyrosine-derived polycarbonate or other structurally related compounds.
- •Patient is receiving chronic oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (diabetes mellitus is not an exclusion criteria).
- •Patient has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.
结局指标
主要结局
Device-Oriented Composite Endpoint (DOCE)
时间窗: 12 months
A composite of cardiac death, target vessel-related non-fatal myocardial infarction (MI) and clinically-driven target lesion revascularization(CD-TLR).
次要结局
- Subcomponents of DOCE(30 days, 6, 12, 24, 36, 48 and 60 months)
- Target vessel revascularization (TVR)(30 days, 6, 12, 24, 36, 48 and 60 months)
- Definite or probable stent thrombosis (ST)(30 days, 6, 12, 24, 36, 48 and 60 months)
研究者
Joost Daemen
Interventional Cardiologist
Erasmus Medical Center
研究点 (3)
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