NCT01350778已完成不适用
Evaluation of Effectiveness and Safety of BIOMATRIX in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Seung-Jung Park20 个研究点 分布在 1 个国家目标入组 837 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 837
- 试验地点
- 20
- 主要终点
- composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
研究概览
简要总结
The objective of this study is to evaluate effectiveness and safety of BioMatrix stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).
详细描述
This study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of BioMatrix stents versus first-generation drug-eluting stent (DES) in patients with coronary artery disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving BioMatrix stents
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •Patients with a mixture of other DESs
- •Terminal illness with life expectancy <1 year
- •Patients with cardiogenic shock
结局指标
主要结局
composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
时间窗: 12 months post procedure
次要结局
- Target-lesion revascularization (TLR)(yearly upto 5 years)
- Cardiac death(yearly upto 5 years)
- TVR(yearly upto 5 years)
- All Death(yearly upto 5 years)
- MI(yearly upto 5 years)
- Composite of death or MI(yearly upto 5 years)
- Composite of cardiac death or MI(yearly upto 5 years)
- Stent thrombosis (ARC criteria)(yearly upto 5 years)
- Procedural success defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization(3 days in average)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (20)
Loading locations...
相似试验
已完成
不适用
BioMimics 3D Stent Clinical Investigation: The Mimics StudyPeripheral Arterial DiseaseNCT02163863Veryan Medical Ltd.86
招募中
不适用
Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff RepairRotator Cuff TearsNCT05894265The University of Texas Health Science Center, Houston72
已完成
不适用
Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial FoldsNasolabial FoldsNCT05612958Dongkook Pharmaceutical Co., Ltd.82
进行中（未招募）
不适用
Multi-sensory Intervention Room Application (MIRA) Device in the NSICUPost Intensive Care SyndromeNCT06509815Icahn School of Medicine at Mount Sinai34
已完成
不适用
Feasibility Study of Meso BioMatrix Device for Breast ReconstructionBreast CancerNCT01823107Kensey Nash Corporation25