Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07742345

Clinical Study of Coronary Extension Catheter

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location status: Recruiting

Location contact

Xiantao Song, PhD

CONTACT

[email protected]

010-63139850

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary Extension Catheter

Device

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

Primary outcomes

  1. Device Delivery Success Rate

    Time frame: Immediately after procedure, 0 day

    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).

Secondary outcomes

  1. Procedural Success Rate

    Time frame: Immediately after procedure, 0 day

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

  2. Device Usage Evaluation

    Time frame: Immediately after procedure, 0 day

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

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

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

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

  4. Adverse Event and Serious Adverse Event

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

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

  5. Device defects

    Time frame: Immediately after procedure, 0 day

    Incidence of device defects.

Study contacts

Contact information is provided by the study sponsor or research team.

Sone, PhD

CONTACT

[email protected]

010-63198850

Sponsors and collaborators

Lead sponsor

BrosMed Medical Co., Ltd

Industry

Registry information

Official study title

A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.