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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. (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Coronary Artery Perforation

Keywords

  • Coronary Artery Perforation
03

In context

Lead sponsor

Shanghai MicroPort Rhythm MedTech Co., Ltd. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Browse Shanghai MicroPort Rhythm MedTech Co., Ltd. studies →All MicroPort Scientific Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Sealing Success

    No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system

    Time frame: Index procedure

  2. 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)

  3. Mortality

    Mortality (Cardiac, cardiovascular, non-cardiovascular)

    Time frame: 1 month, 6 months, and 1 year postoperatively

  4. 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

  5. Target Lesion Revascularization

    Target Lesion Revascularization (ischemia-driven, non ischemia-driven)

    Time frame: 1 month, 6 months, and 1 year postoperatively

  6. Target Vessel Revascularization

    Target Vessel Revascularization (ischemia-driven, non ischemia-driven)

    Time frame: 1 month, 6 months, and 1 year postoperatively

  7. 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

  8. Stent thrombosis rate

    s (by Academic Research Consortium \[ARC\] definitions)

    Time frame: 1 month, 6 months, and 1 year postoperatively

  9. AEs and SAEs

    Adverse Events and Severe Adverse Events

    Time frame: 1 month, 6 months, and 1 year postoperatively

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Jilin University
    Chang chun, Jilin 130061, China
    Recruiting
    • Qian Tong · Contact
    • Qian Tong, M.D. · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Jul 2025, 33 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2022
First posted
Jun 1, 2022
StartActual
Oct 26, 2022
Primary completionEst.
Jul 2025
CompletionEst.
Jul 2025
Last update
Mar 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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