NCT05398991Unknown不适用
A Prospective, Multicenter, Single-arm Trial of Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
Shanghai MicroPort Rhythm MedTech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年10月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Procedural Success
研究概览
简要总结
A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.
详细描述
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Coronary Covered Stents System for the treatment of coronary artery perforation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •General Inclusion Criteria
- •Subjects aged ≥ 18 years.
- •Subjects with perforated coronary or aortic-coronary bypass graft vessels.
- •Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
- •Angiography Inclusion Criteria
- •The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III.
- •Reference vessel diameter from 2.5 mm to 4.0 mm.
- •According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered.
- •Up to one perforated lesion will be treated and up to one covered stent expected to be implanted.
排除标准
- •Subjects who are unable to receive anticoagulation or antiplatelet therapy.
- •Subjects who are unable to tolerate 6 months of DAPT treatment.
- •Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene.
- •According to the judgment of the investigator, subjects who are poorly compliant and unable to complete the study as required; or subjects who are otherwise deemed unsuitable for the enrollment.
- •Primary or secondary cryptogenic coronary perforation or bleeding.
- •Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO.
- •Angiographic Exclusion Criteria
- •anatomical structures proximal to the target lesion or within the lesion (e.g., severe tortuosity, etc.) that would obstruct delivery of the coronary covered stent.
- •implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.
- •left or right coronary opening area or coronary sinus entrapment.
- •balloon dilation can not relieve bleeding symptoms
- •Subjects who need to implant two or more covered stents
- •primary or secondary unexplained coronary perforation, or ≥ 2 perforation sites.
- •Other conditions that are not suitable for covered stents treatment.
研究组 & 干预措施
Experimental Arm
Experimental
Subjects in experimental group will be implanted with the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.
干预措施: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. (Device)
结局指标
主要结局
Procedural Success
时间窗: During hospitalization (up to 7 days after procedure)
Successful implantation of a coronary covered stent and sealing of the perforation with ≤30% diameter stenosis(visual inspection) and TIMI III with no blood spillage requiring urgent surgical intervention.
次要结局
- Sealing Success(Index procedure)
- Target Lesion Revascularization(1 month, 6 months, and 1 year postoperatively)
- Rate of emergency surgery or additional pericardial tamponade/puncture postoperatively(1 month, 6 months, and 1 year postoperatively)
- AEs and SAEs(1 month, 6 months, and 1 year postoperatively)
- Clinical Success(During hospitalization (up to 7 days after procedure))
- Mortality(1 month, 6 months, and 1 year postoperatively)
- Myocardial Infarction(1 month, 6 months, and 1 year postoperatively)
- Target Vessel Revascularization(1 month, 6 months, and 1 year postoperatively)
- Stent thrombosis rate(1 month, 6 months, and 1 year postoperatively)
研究者
研究点 (1)
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