Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

NCT05398991 | Recruiting DMC

• 1 other identifier: D-MC-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Perforation

Keywords

Coronary Artery Perforation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Sealing Success

  Index procedure

• Clinical Success

  During hospitalization (up to 7 days after procedure)

• Mortality

  1 month, 6 months, and 1 year postoperatively

• Myocardial Infarction

  1 month, 6 months, and 1 year postoperatively

• Target Lesion Revascularization

  1 month, 6 months, and 1 year postoperatively

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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.

Interventions

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

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 18 years.
• Subjects with perforated coronary or aortic-coronary bypass graft vessels.
• 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.
• The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III.
• Reference vessel diameter from 2.5 mm to 4.0 mm.
• According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered.
• Up to one perforated lesion will be treated and up to one covered stent expected to be implanted.

You may not qualify if:

• Subjects who are unable to receive anticoagulation or antiplatelet therapy.
• Subjects who are unable to tolerate 6 months of DAPT treatment.
• Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene.
• 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.
• Primary or secondary cryptogenic coronary perforation or bleeding.
• Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO.
• 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.
• implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.
• left or right coronary opening area or coronary sinus entrapment.
• balloon dilation can not relieve bleeding symptoms
• Subjects who need to implant two or more covered stents
• primary or secondary unexplained coronary perforation, or ≥ 2 perforation sites.
• Other conditions that are not suitable for covered stents treatment.

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130061, China

RECRUITING

Study Officials

• Qian Tong, M.D.

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruifen Cao, M.M.

CONTACT

0086-021-38954600; RuiFen.Cao@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 1, 2022
• Study Start: October 26, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)