Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

Study Overview
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Brief Summary
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A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Single-arm Trial of Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

Conditions
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Coronary Artery Perforation

Intervention / Treatment
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* Device: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.


Participation Criteria
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Eligibility Criteria
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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. General Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Subjects in experimental group will be implanted with the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. | Device: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.<br>* the Coronary Covered Stents System contains a covered stent and a delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | 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. | During hospitalization (up to 7 days after procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealing Success | No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system | Index procedure | 
| Clinical Success | on the basis of procedure success with no device-related composite endpoint events during hospitalization (up to 7 days after procedure) | During hospitalization (up to 7 days after procedure) | 
| Mortality | Mortality (Cardiac, cardiovascular, non-cardiovascular) | 1 month, 6 months, and 1 year postoperatively | 
| Myocardial Infarction | Myocardial Infarction (Fourth Universal Definition of Myocardial Infarction) | 1 month, 6 months, and 1 year postoperatively | 
| Target Lesion Revascularization | Target Lesion Revascularization (ischemia-driven, non ischemia-driven) | 1 month, 6 months, and 1 year postoperatively | 
| Target Vessel Revascularization | Target Vessel Revascularization (ischemia-driven, non ischemia-driven) | 1 month, 6 months, and 1 year postoperatively | 
| Rate of emergency surgery or additional pericardial tamponade/puncture postoperatively | the rate of events caused an emergency surgery, additional pericardial tamponade or puncture postoperatively | 1 month, 6 months, and 1 year postoperatively | 
| Stent thrombosis rate | s (by Academic Research Consortium [ARC] definitions) | 1 month, 6 months, and 1 year postoperatively | 
| AEs and SAEs | Adverse Events and Severe Adverse Events | 1 month, 6 months, and 1 year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Perforation