Clinical trial NCT05398991: Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
Official title: A Prospective, Multicenter, Single-arm Trial of Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Perforation
Keywords: Coronary Artery Perforation
Lead sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Procedural Success
timeFrame: During hospitalization (up to 7 days after procedure)
Secondary outcomes:
measure: Sealing Success
timeFrame: Index procedure
measure: Clinical Success
timeFrame: During hospitalization (up to 7 days after procedure)
measure: Mortality
timeFrame: 1 month, 6 months, and 1 year postoperatively
measure: Myocardial Infarction
timeFrame: 1 month, 6 months, and 1 year postoperatively
measure: Target Lesion Revascularization
timeFrame: 1 month, 6 months, and 1 year postoperatively
measure: Target Vessel Revascularization
timeFrame: 1 month, 6 months, and 1 year postoperatively
measure: Rate of emergency surgery or additional pericardial tamponade/puncture postoperatively
timeFrame: 1 month, 6 months, and 1 year postoperatively
measure: Stent thrombosis rate
timeFrame: 1 month, 6 months, and 1 year postoperatively
measure: AEs and SAEs
timeFrame: 1 month, 6 months, and 1 year postoperatively
Other outcomes:
Locations:
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Qian Tong, M.D.
role: PRINCIPAL_INVESTIGATOR
References: