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

MicroPort

Status: Enrolling

Conditions: Coronary Artery Perforation

Treatments: Device: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05398991

D-MC-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Experimental Arm

Experimental group

Description:

Subjects in experimental group will be implanted with the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.

Treatment:

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