The Direct III Post Market Study (Direct III)
Direct Implantation of Sirolimus-Eluting Stents With Bioresorbable Drug Carrier Technology Utilizing the Svelte Drug-Eluting Coronary Stent: The Direct III Post Market Study
研究概览
地位
条件
详细说明
In this post-market study, the population will include real-world subjects who are intended to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will be made for clinical assessments at hospital discharge, 1, 6 and 12 months.
This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population. A minimum of two hundred fifty (250) subjects will be treated at up to 20 sites in Europe.
Review of safety data and risks to subjects will be monitored by an independent Clinical Events Committee (CEC) at pre-specified enrollment milestones.
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
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Amersfoort、荷兰
- Meander Medical Center
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Amsterdam、荷兰、1091 AC
- OLVG
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Blaricum、荷兰、1261AN
- Tergooi Hospital
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Breda、荷兰、4819 EV
- Amphia Ziekenhuis
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Dordrecht、荷兰、3300 AK
- Albert Schweitzer Hospital
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Nieuwegein、荷兰、3430 EM
- St Antonius hospital
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The Hague、荷兰、2545 AA
- HagaZiekenhuis
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Utrecht、荷兰
- University Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Subject is ≥ 18 years old;
- Subject has symptomatic heart disease due to coronary artery lesions of length < 28 mm and a reference vessel diameter 2.5 - 4.0 mm.
- Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment
- Subject or subject's legal representative understands the study requirements and the treatment procedures and provides written informed consent before any study specific tests or procedures are performed.
Exclusion Criteria:
- Subject is unable to receive anti-platelet and/or anti-coagulant therapy;
- Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten;
- The subject is judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent, including chronic total occlusions.
- Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential, based on the standard of care for the cath lab);
- Subject is participating in another investigational drug or device clinical trial that the investigator feels would interfere with the subject's participation in this study.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Target Lesion Failure (TLF)
大体时间:12 months
|
Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
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12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Target Vessel Failure (TVF)
大体时间:Discharge, 1, 6 and 12 months
|
composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods.
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Discharge, 1, 6 and 12 months
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Major Adverse Cardiac Event (MACE)
大体时间:Discharge, 1, 6 and 12 months
|
defined as a composite of all deaths, Target Vessel MI (Q wave and non-Q wave), emergent coronary artery bypass grafting surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
|
Discharge, 1, 6 and 12 months
|
合作者和调查者
调查人员
- 研究主任:Dennis Donohoe, MD、Svelte Medical
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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