A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
the Coronary Covered Stents System contains a covered stent and a delivery system
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGProcedural 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.
Time frame: During hospitalization (up to 7 days after procedure)
Sealing Success
No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system
Time frame: 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)
Time frame: During hospitalization (up to 7 days after procedure)
Mortality
Mortality (Cardiac, cardiovascular, non-cardiovascular)
Time frame: 1 month, 6 months, and 1 year postoperatively
Myocardial Infarction
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.
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Time frame: 1 month, 6 months, and 1 year postoperatively
Target Lesion Revascularization
Target Lesion Revascularization (ischemia-driven, non ischemia-driven)
Time frame: 1 month, 6 months, and 1 year postoperatively
Target Vessel Revascularization
Target Vessel Revascularization (ischemia-driven, non ischemia-driven)
Time frame: 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
Time frame: 1 month, 6 months, and 1 year postoperatively
Stent thrombosis rate
s (by Academic Research Consortium \[ARC\] definitions)
Time frame: 1 month, 6 months, and 1 year postoperatively
AEs and SAEs
Adverse Events and Severe Adverse Events
Time frame: 1 month, 6 months, and 1 year postoperatively