Coronary Artery Perforation
Conditions
Keywords
Coronary Artery Perforation
Brief summary
A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.
Detailed description
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.
Interventions
DEVICEthe Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.
the Coronary Covered Stents System contains a covered stent and a delivery system
Sponsors
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Subjects aged ≥ 18 years. 2. Subjects with perforated coronary or aortic-coronary bypass graft vessels. 3. 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 1. The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III. 2. Reference vessel diameter from 2.5 mm to 4.0 mm. 3. According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered. 4. Up to one perforated lesion will be treated and up to one covered stent expected to be implanted. General
Exclusion criteria
1. Subjects who are unable to receive anticoagulation or antiplatelet therapy. 2. Subjects who are unable to tolerate 6 months of DAPT treatment. 3. Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene. 4. 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. 5. Primary or secondary cryptogenic coronary perforation or bleeding. 6. Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | During hospitalization (up to 7 days after procedure) | on the basis of procedure success with no device-related composite endpoint events during hospitalization (up to 7 days after procedure) |
| Mortality | 1 month, 6 months, and 1 year postoperatively | Mortality (Cardiac, cardiovascular, non-cardiovascular) |
| Myocardial Infarction | 1 month, 6 months, and 1 year postoperatively | As per Myocardial Infarction (Fourth Universal Definition of Myocardial Infarction) types 1, 2 and 3 MI: have the clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: * Symptoms of myocardial ischaemia; * New ischaemic ECG changes; * Development of pathological Q waves; * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology; * Identification of a coronary thrombus by angiography or autopsy (not for types 2 or 3 MIs). types 4 and 5 MI: Coronary procedure-related MI ≤ 48 hours after the index procedure is arbitrarily defined by an elevation of cTn values \> 5 times for type 4a MI and \> 10 times for type 5 MI of the 99th percentile URL in patients with normal baseline values. |
| Target Lesion Revascularization | 1 month, 6 months, and 1 year postoperatively | Target Lesion Revascularization (ischemia-driven, non ischemia-driven) |
| Sealing Success | Index procedure | No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system |
| Rate of emergency surgery or additional pericardial tamponade/puncture postoperatively | 1 month, 6 months, and 1 year postoperatively | the rate of events caused an emergency surgery, additional pericardial tamponade or puncture postoperatively |
| Stent thrombosis rate | 1 month, 6 months, and 1 year postoperatively | s (by Academic Research Consortium \[ARC\] definitions) |
| AEs and SAEs | 1 month, 6 months, and 1 year postoperatively | Adverse Events and Severe Adverse Events |
| Target Vessel Revascularization | 1 month, 6 months, and 1 year postoperatively | Target Vessel Revascularization (ischemia-driven, non ischemia-driven) |
Countries
China
Contacts
Primary ContactRuifen Cao, M.M.
Outcome results
None listed