Clinical Study of Coronary Extension Catheter

NCT07742345 | Recruiting

• 1 other identifier: BM-D28
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Percutaneous Coronary Intervention (PCI)

Outcome Measures

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).

  Immediately after procedure, 0 day

Secondary Outcomes (5)

• Procedural Success Rate

  Immediately after procedure, 0 day

• Device Usage Evaluation

  Immediately after procedure, 0 day

• Adverse events and serious adverse events related to the study device

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

• Adverse Event and Serious Adverse Event

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

• Device defects

  Immediately after procedure, 0 day

Study Arms (1)

test group

EXPERIMENTAL

Device: Coronary Extension Catheter

Interventions

Coronary Extension Catheter DEVICE

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

test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Sone, PhD

CONTACT

010-63198850; songxiantao0929@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)