Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation (CONVOY)

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

A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Perforation
• Intervention / Treatment: Device: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruifen Cao, M.M.; Phone Number: 8102 0086-021-38954600; Email: RuiFen.Cao@microport.com

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China, 130061
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Qian Tong
      • Principal Investigator: Qian Tong, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Exclusion Criteria

1. 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.
2. implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.
3. left or right coronary opening area or coronary sinus entrapment.
4. balloon dilation can not relieve bleeding symptoms
5. Subjects who need to implant two or more covered stents
6. primary or secondary unexplained coronary perforation, or ≥ 2 perforation sites.
7. Other conditions that are not suitable for covered stents treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; 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.; the Coronary Covered Stents System contains a covered stent and a delivery system

What is the study measuring?

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
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
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.	1 month, 6 months, and 1 year postoperatively

Collaborators and Investigators

• Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.
• Investigators: Principal Investigator: Qian Tong, M.D., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Coronary Artery Perforation
• Other Study ID Numbers: D-MC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No