ClinicalTrials.gg
RecruitingNCT07742345Updated Aug 3, 2026

Clinical Study of Coronary Extension Catheter

An interventional study of Coronary Extension Catheter in Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), sponsored by BrosMed Medical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by BrosMed Medical Co., Ltd · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 543 studies in Coronary Artery Disease with a site in China — 176 open to participants now, 210 under way, 6 of them phase 3. Coronary Artery Disease · China.

Planned enrollment
276th of 324
69 · median 307
Started
2026
with 54 others
No phase
210 of 543
71 open now
Primary completion
2027-04
later than 120 of 209 live
Registered
520th of 543
by date

Among the 543 studies in Coronary Artery Disease with a site in China, this one is the 276th largest by planned enrollment of the 324 interventional ones that give a count, is one of 55 that started in 2026, is one of 210 with no phase, reaches primary completion later than 120 of the 209 other live ones, and was the 520th registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

176 of the 543 studies in Coronary Artery Disease with a site in China are open now. Recruiting first, the newest first:

170 more — sign in →

All 176 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 543 studies in Coronary Artery Disease with a site in China, or all of them as a file.
02

Study summary

This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters. The safety and efficacy of these catheters in percutaneous coronary intervention will be assessed through the collection and analysis of efficacy and safety endpoints during treatment and follow-up.

03

Conditions studied

  • Coronary Artery Disease (CAD)
  • Percutaneous Coronary Intervention (PCI)

Keywords

  • Percutaneous Coronary Intervention (PCI)
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years, regardless of gender;
  • Patients suitable for percutaneous coronary intervention (PCI) and for whom the use of an extension catheter is planned to assist the intervention;
  • Ability to understand the purpose of the study, willingness to voluntarily participate, and ability to provide written .

Exclusion criteria

Exclusion Criteria:

  • Reference vessel diameter \< 2 mm;
  • Presence of thrombus in the target vessel;
  • Unprotected left main coronary artery disease;
  • Acute myocardial infarction occurring within 7 days prior to enrollment;
  • Known intolerance to anticoagulant or antiplatelet therapy, or known allergy to contrast media;
  • Concurrent severe hepatic or renal disease, or other severe systemic conditions that render the patient unsuitable for PCI;
  • Pregnant or lactating women;
  • Currently participating in another clinical trial of a drug or medical device without having reached the primary endpoint or completed the trial;
  • Any other condition that, in the investigator's opinion, makes the patient ineligible for participation in this study.
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
69 participants (estimated)

Study arms

  • Experimental
    test group

    Device: Coronary Extension Catheter

Interventions

  • DeviceCoronary Extension Catheter

    For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.

06

What researchers measure

Primary outcomes

  1. Device Delivery Success Rate

    Device delivery success is defined as the successful delivery of the target device (balloon and/or stent) to the target lesion after the use of the study device during percutaneous coronary intervention (PCI).

    Time frame: Immediately after procedure, 0 day

Secondary outcomes

  1. Procedural Success Rate

    Procedural success is defined as residual stenosis of the target lesion ≤30% (by visual estimation) and TIMI flow grade 3 after PCI.

    Time frame: Immediately after procedure, 0 day

  2. Device Usage Evaluation

    The device usage evaluation includes: pushability, support, overall ease of use, device trackability, and radiopacity. There are four grades, ranging from poor to excellent.

    Time frame: Immediately after procedure, 0 day

  3. Adverse events and serious adverse events related to the study device

    Adverse events and serious adverse events related to the study device during the study.

    Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)

  4. Adverse Event and Serious Adverse Event

    Occurrence of adverse events and serious adverse events during the study.

    Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)

  5. Device defects

    Incidence of device defects.

    Time frame: Immediately after procedure, 0 day

07

Study locations

1 of 1 sites recruiting
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 reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 10 months after the start.

Of 177 industry-sponsored interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's planned 10 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

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

Registered
Jul 23, 2026
First posted
Aug 3, 2026
StartActual
Jun 25, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Apr 30, 2027
Last update
Aug 3, 2026
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 Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07742345
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Jun 25, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

Sone, PhD
Contact
songxiantao0929@qq.com
010-63198850

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion