Coronary Artery PerforationCONVOYNCT05398991
Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
A study testing the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. in people with Coronary Artery Perforation, run by Shanghai MicroPort Rhythm MedTech Co., Ltd. at 1 site in China.
Trial summary
A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Perforation
- What is being tested?
- the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130061
Qian Tong
Qian Tong, M.D.
About this study
Official title: A Prospective, Multicenter, Single-arm Trial of Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
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
- Coronary Artery Perforation
- Being tested
- the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.
- Keywords
- Coronary Artery Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.Device
the Coronary Covered Stents System contains a covered stent and a delivery system
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Subjects in experimental group will be implanted with the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. Receives: Device: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospitalization (up to 7 days after procedure)
Secondary outcomes (9)
Sealing Success
No residual blood spillage requiring urgent surgical intervention after successful release of the stent delivery system
Measured: 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)
Measured: During hospitalization (up to 7 days after procedure)
Mortality
Mortality (Cardiac, cardiovascular, non-cardiovascular)
Measured: 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.
Measured: 1 month, 6 months, and 1 year postoperatively
Target Lesion Revascularization
Target Lesion Revascularization (ischemia-driven, non ischemia-driven)
Measured: 1 month, 6 months, and 1 year postoperatively
Target Vessel Revascularization
Target Vessel Revascularization (ischemia-driven, non ischemia-driven)
Measured: 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
Measured: 1 month, 6 months, and 1 year postoperatively
Stent thrombosis rate
s (by Academic Research Consortium [ARC] definitions)
Measured: 1 month, 6 months, and 1 year postoperatively
AEs and SAEs
Adverse Events and Severe Adverse Events
Measured: 1 month, 6 months, and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start26 Oct 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qian Tong, M.D., Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398991
- Sponsor's protocol ID
- D-MC-001
- Acronym
- CONVOY
- Status last verified
- Mar 2024
- First submitted
- 20 May 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Trial of Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
- ClinicalTrials.gov ID
- NCT05398991
- Acronym / sponsor ID
- CONVOY / D-MC-001
- Conditions
- Coronary Artery Perforation
- Keywords
- Coronary Artery Perforation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd.Subjects in experimental group will be implanted with the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the 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 | Device | Experimental Arm |
Primary outcome
Procedural Success
Time frame: During hospitalization (up to 7 days after procedure)
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.
9 secondary outcomes
Sealing Success
Time frame: Index procedure
Clinical Success
Time frame: During hospitalization (up to 7 days after procedure)
Mortality
Time frame: 1 month, 6 months, and 1 year postoperatively
Myocardial Infarction
Time frame: 1 month, 6 months, and 1 year postoperatively
Target Lesion Revascularization
Time frame: 1 month, 6 months, and 1 year postoperatively
Target Vessel Revascularization
Time frame: 1 month, 6 months, and 1 year postoperatively
Rate of emergency surgery or additional pericardial tamponade/puncture postoperatively
Time frame: 1 month, 6 months, and 1 year postoperatively
Stent thrombosis rate
Time frame: 1 month, 6 months, and 1 year postoperatively
AEs and SAEs
Time frame: 1 month, 6 months, and 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Tong, M.D. principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Coronary Covered Stents System manufactured by Shanghai MicroPort Medical (Group) Co., Ltd. in people with Coronary Artery Perforation, run by Shanghai MicroPort Rhythm MedTech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruifen Cao, M.M. (0086-021-38954600 ext. 8102, RuiFen.Cao@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: During hospitalization (up to 7 days after procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.