NCT02121223Unknown不适用
A Prospective, Multi-center,Randomized Controled Trial of POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary PCI After Thrombus Aspiration and DES Implantation With OCT Assessment
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
研究概览
简要总结
To evaluate the effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with drug-eluting stents .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Clinical Inclusion Criteria:
- •Age ≥18 years
- •STEMI >20 mins and <12 hours in duration
- •ST-segment elevation of ≥1 mm in ≥2 contiguous leads; or Presumably new left bundle branch block; or True posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads
- •Written, informed consent
- •Angiographic Inclusion Criteria
- •The presence of least 1 acute infarct artery target vessel* in which:
- •ALL significant lesions are eligible for stenting with study stents, and
- •ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
- •All culprit lesion TIMI Flow ≤ 0 or 1 Grade prior to guide wire crossing
- •Expected ability to deliver the stent(s) to all culprit lesions (absence of excessive proximal tortuosity or severe calcification)
- •Expected ability to fully expand the stent(s) at all culprit lesions (absence of marked calcification)
排除标准
- •Contraindication to any of the study medications
- •Patients with cardiogenic shock
- •History of bleeding diathesis or known coagulopathy , or will refuse blood transfusions
- •History of intracerebral mass, aneurysm, AVM, or hemorrhagic stroke; stroke or TIA within 6 months or any permanent neurologic deficit; GI or GU bleed within 2 months, or major surgery within 6 weeks; recent or known platelet count <100,000 cells/mm3 or hgb <10 g/dL
- •Planned elective surgical procedure that would necessitate interruption of thienopyridines during the first 6 months post enrollment
- •Angiographic Exclusion Criteria
- •Bifurcation lesion definitely requiring implantation of stents in both the main vessel + side branch
- •Infarct related artery is an unprotected left main
- •>38 mm of study stent length anticipated
- •Infarction due to stent thrombosis, or infarct lesion at the site of a previously implanted stent
- •High likelihood of CABG within 30 days anticipated
- •The culprit lesion will be judged unsuitable for OCT procedure, because of conditions such as left main trunk disease or shock vital
结局指标
主要结局
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
时间窗: 7 months after primary PCI
次要结局
- Final TIMI flow grade 3(Immediately after primary PCI procedure (up to 2 min))
- Final TIMI blush Grade 3(Immediately after primary PCI procedure (up to 2 min))
- In-stent and in-segment late loss(7 months after primary PCI)
- Rate of strut coverage in OCT at 7 month(7 months after primary PCI)
- Stent thrombus rate at 30 day,7 month and 12 month(30 days, 7 months and 12 months after primary PCI)
- Rate of ST resolution 70% at 30 day(30 days after primary PCI)
- TLR ,TLF at 7 month and 12 month(7 months and 12months after primary PCI)
- MACE at 7 month and 12 month(7 months and 12 months after primary PCI)
研究者
Jian'an Wang,MD,PhD
Professor, Chief of Heart Center, and President of the Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (1)
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