Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

Launched by SHANGHAI MICROPORT RHYTHM MEDTECH CO., LTD. · May 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Coronary Covered Stents, which are special devices used to repair holes (or perforations) in the coronary arteries. These perforations can happen during certain procedures or due to other medical issues, and they can be serious. The trial is currently looking for participants aged 18 and older who have a specific type of coronary artery or aortic bypass graft perforation that needs treatment. To participate, individuals must be able to understand the study and agree to take part by signing a consent form.

Participants in this trial can expect to receive careful monitoring and follow-up care after their treatment with the covered stent. It's important to note that individuals who have certain allergies, cannot take blood-thinning medications, or have specific medical conditions may not be eligible to join the study. This trial aims to see how well these covered stents can help patients with coronary artery perforations, which could lead to better treatment options in the future.

Gender

ALL

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.