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Evaluation of Safety and Effectiveness of Coronary Extension Catheters Used During Percutaneous Coronary Intervention for Coronary Artery Disease
Led by BrosMed Medical Co., Ltd · Updated on 2026-08-03
69
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the use of coronary extension catheters in patients with coronary artery disease undergoing percutaneous coronary intervention PCI. This prospective, multicenter, single-arm study will evaluate the safety and effectiveness of these catheters by collecting data on treatment outcomes and potential complications. The study aims to better understand how these devices perform during heart procedures. Participants who meet the criteria will receive treatment using the BM coronary extension catheter during their PCI procedure. This device is being studied to assist the intervention by extending reach within the coronary arteries. The study focuses on immediate procedure outcomes and safety, monitoring patients through hospital discharge, usually within seven days. During the study, participants will be closely monitored for device delivery success, procedural success, and any adverse events related to the catheter. Assessments will take place immediately after the procedure and continue until hospital discharge. Researchers will also evaluate device usage and any device defects. Overall participation will last from the procedure day until discharge, with detailed safety and efficacy data collected during this period.
CONDITIONS
Brief Title
Clinical Study of Coronary Extension Catheter
Research Team
S
Sone, PhD
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