Using covered stents to treat coronary artery perforation

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

This study is testing a new type of covered stent to see if it can safely help adults with certain kinds of coronary artery perforations.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Chang chun, Jilin)
• Trial ID: NCT05398991 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Coronary Covered Stents System for treating coronary artery perforation. It involves patients aged 18 and older who have specific types of perforations in their coronary or aortic-coronary bypass graft vessels. Participants will receive the covered stent to address their condition, with careful monitoring throughout the process to assess outcomes. The study aims to gather data that could support the use of this intervention in clinical practice.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific types of coronary artery or aortic bypass graft perforations.

Not a fit: Patients who cannot receive anticoagulation or antiplatelet therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients experiencing coronary artery perforation.

How similar studies have performed: While this approach is being evaluated in this trial, similar interventions have shown promise in treating vascular complications, suggesting potential for success.

Eligibility 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.

Where this trial is running

Chang chun, Jilin

• The First Hospital of Jilin University — Chang chun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Qian Tong, M.D. — The First Hospital of Jilin University
• Study coordinator: Ruifen Cao, M.M.

Conditions Coronary Artery Perforation