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Can a new catheter make heart stenting safer and more effective?

NCT ID NCT07742345

Disease control Sponsor: BrosMed Medical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing a new coronary extension catheter designed to help doctors deliver balloons and stents more easily during percutaneous coronary intervention (PCI) for coronary artery disease. The study will enroll about 69 adults who need PCI and for whom the catheter is planned to assist the procedure. Researchers will measure how often the device successfully delivers the stent, overall procedural success, and safety outcomes during follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Coronary extension catheter (a device used during percutaneous coronary intervention to help deliver balloons and stents to the target lesion)
What this could lead to
If successful, this catheter could make complex coronary stenting procedures safer and more effective, potentially improving outcomes for people with coronary artery disease.
What could go wrong
This is a small, single-arm study without a comparison group, so results may not be definitive. As with any invasive procedure, there are risks such as vessel damage or complications during PCI.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 69 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 informed consent. 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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease (CAD) Percutaneous coronary intervention (PCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, 100050, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.