Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

Not Applicable

Recruiting

• Conditions: Coronary Artery Perforation

• Registration Number: NCT05398991
• Lead Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-06-01
• Study Start: 2022-10-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sealing Success	Index procedure	No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system
Target Lesion Revascularization	1 month, 6 months, and 1 year postoperatively	Target Lesion Revascularization (ischemia-driven, non ischemia-driven)
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
AEs and SAEs	1 month, 6 months, and 1 year postoperatively	Adverse Events and Severe Adverse Events
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 Vessel Revascularization	1 month, 6 months, and 1 year postoperatively	Target Vessel Revascularization (ischemia-driven, non ischemia-driven)
Stent thrombosis rate	1 month, 6 months, and 1 year postoperatively	s (by Academic Research Consortium \[ARC\] definitions)

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China