Clinical Study of Coronary Extension Catheter
A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
BrosMed Medical Co., Ltd
69 participants
Jun 25, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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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Interventions
For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07742345