Coronary Extension Catheter: For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Device Delivery Success Rate — 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).
Trial sites (1)
Facility
City
Region
Status
Beijing Friendship Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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