Coronary Artery DiseaseNCT05747287
Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
A study testing microcatheter in people with Coronary Artery Disease and Peripheral Arterial Disease, run by BrosMed Medical Co., Ltd at 3 sites in China.
Trial summary
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Peripheral Arterial Disease
- What is being tested?
- microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 17 Jan 2023to 22 Dec 2023
- 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
Who may be able to join
- Age ≥ 18 years old;
- Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
- Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
- Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.
Who cannot join
- Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
- Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
- Patients with in-stent occlusion;
- Patients with unprotected left main coronary artery disease;
- Women who are pregnant or lactating;
- Patients who are participating in clinical trials of other drugs or medical devices;
- Patients with contraindications to the investigational device;
- Other patients considered by the investigators to be unsuitable for this trial.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Shijiazhuang People's Hospital
Shijiazhuang, Hebei
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
The Seventh People's Hospital of Zhengzhou
Zhengzhou, Henan
About this study
Official title: A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
- Being tested
- microcatheter
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microcatheterDevice
supports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom.
Measured: 0 day
Secondary outcomes (5)
Device success
Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal.
Measured: 0 day
Procedural success
Defined as meeting all the following criteria:
- After PCI, the final diameter stenosis of the target lesion achieves ≤30%, and the TIMI returns to grade 3;
- No all-cause death, Q-wave myocardial infarction, stroke, cardiac tamponade, target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) before discharge.
Measured: 0 - 7 days
Device super-selective angiography (if applicable)
the microcatheter shall deliver the contrast agent to the designated location and develop
Measured: 0 day
Guide wire exchange supported (if applicable)
successful exchange of the guide wire
Measured: 0 day
Device Performance Evaluation
The investigators will evaluate the device performance according to the use and operation of the device during the procedure
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start17 Jan 2023
- Primary completion3 Oct 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747287
- Sponsor's protocol ID
- S02
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
- ClinicalTrials.gov ID
- NCT05747287
- Acronym / sponsor ID
- S02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 28 Feb 2023 (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.
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: microcatheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old;
- Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
- Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
- Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.
Key exclusion criteria (8 listed)
- Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
- Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
- Patients with in-stent occlusion;
- Patients with unprotected left main coronary artery disease;
- Women who are pregnant or lactating;
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 |
|---|---|---|
| microcathetersupports the insertion of the guide wire，exchange of the guide wire and the delivery of contrast media | Device | Experimental group |
Primary outcome
Technical success
Time frame: 0 day
Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom.
5 secondary outcomes
Device success
Time frame: 0 day
Procedural success
Time frame: 0 - 7 days
Device super-selective angiography (if applicable)
Time frame: 0 day
Guide wire exchange supported (if applicable)
Time frame: 0 day
Device Performance Evaluation
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microcatheter in people with Coronary Artery Disease and Peripheral Arterial Disease, run by BrosMed Medical Co., Ltd at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: 0 day). 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 19 Jan 2024.