Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-26

Study Completion Date

2025-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Perforation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

the Coronary Covered Stents System contains a covered stent and a delivery system

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No