RecruitingNCT05398991CONVOYUpdated Mar 21, 2024

Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

An interventional study of the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. in Coronary Artery Perforation, sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by Shanghai MicroPort Rhythm MedTech Co., Ltd. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 28
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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.

Conditions studied

Coronary Artery Perforation

Keywords

Coronary Artery Perforation

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

General Inclusion Criteria

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.

Angiography Inclusion Criteria

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.

General Exclusion Criteria

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.

Angiographic Exclusion Criteria

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 28 participants (estimated)

Study arms

Experimental
Experimental Arm
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

Devicethe 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

What researchers measure

Primary outcomes

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.
Time frame: During hospitalization (up to 7 days after procedure)

Secondary outcomes

Sealing Success
No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system
Time frame: Index procedure
Clinical Success
on the basis of procedure success with no device-related composite endpoint events during hospitalization (up to 7 days after procedure)
Time frame: During hospitalization (up to 7 days after procedure)
Mortality
Mortality (Cardiac, cardiovascular, non-cardiovascular)
Time frame: 1 month, 6 months, and 1 year postoperatively
Myocardial Infarction
As per Myocardial Infarction (Fourth Universal Definition of Myocardial Infarction) types 1, 2 and 3 MI: have the clinical evidence of acute myocardial ischaemia and with detection of a rise and/or fall of cTn values with at least one value above the 99th percentile URL and at least one of the following: * Symptoms of myocardial ischaemia; * New ischaemic ECG changes; * Development of pathological Q waves; * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology; * Identification of a coronary thrombus by angiography or autopsy (not for types 2 or 3 MIs). types 4 and 5 MI: Coronary procedure-related MI ≤ 48 hours after the index procedure is arbitrarily defined by an elevation of cTn values \> 5 times for type 4a MI and \> 10 times for type 5 MI of the 99th percentile URL in patients with normal baseline values.
Time frame: 1 month, 6 months, and 1 year postoperatively
Target Lesion Revascularization
Target Lesion Revascularization (ischemia-driven, non ischemia-driven)
Time frame: 1 month, 6 months, and 1 year postoperatively
Target Vessel Revascularization
Target Vessel Revascularization (ischemia-driven, non ischemia-driven)
Time frame: 1 month, 6 months, and 1 year postoperatively
Rate of emergency surgery or additional pericardial tamponade/puncture postoperatively
the rate of events caused an emergency surgery, additional pericardial tamponade or puncture postoperatively
Time frame: 1 month, 6 months, and 1 year postoperatively
Stent thrombosis rate
s (by Academic Research Consortium \[ARC\] definitions)
Time frame: 1 month, 6 months, and 1 year postoperatively
AEs and SAEs
Adverse Events and Severe Adverse Events
Time frame: 1 month, 6 months, and 1 year postoperatively

Study locations

1 of 1 sites recruiting

The First Hospital of Jilin University
Chang chun, Jilin 130061, China
- Qian Tong · Contact
- Qian Tong, M.D. · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05398991
Lead sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.
Responsible party: Sponsor
First posted: Jun 1, 2022
Start date: Oct 26, 2022
Primary completion: Jul 2025 (estimated)
Completion: Jul 2025 (estimated)
Last update: Mar 21, 2024

Study contacts

Ruifen Cao, M.M.

Contact

RuiFen.Cao@microport.com

0086-021-38954600 ext. 8102

Qian Tong, M.D.

principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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