NCT07742345RecruitingNot Applicable
A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- BrosMed Medical Co., Ltd
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Device Delivery Success Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Study Sites (1)
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