NL-OMON49058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 - ENCORE-I
Trialbureau Cardiologie0 个研究点目标入组 26 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 ACS.
- •- 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
- •- 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
- •- 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
研究者
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