A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
| Registry | NCT07742345 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 69 (Estimated) |
| Sponsor | BrosMed Medical Co., Ltd (Industry) |
| Conditions | Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI) |
| Interventions | Coronary Extension Catheter (Device) |
| Dates | start 2026-06-25, primary completion 2027-04-30 (estimated), completion 2027-04-30 (estimated), first posted 2026-08-03, last updated 2026-08-03 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Disease (CAD) All trials for Percutaneous Coronary Intervention (PCI) All trials 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| test group | Experimental | Device: Coronary Extension Catheter |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | China | Recruiting |