Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Location status: Recruiting
NCT Number: NCT07742345
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, 100050, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
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).
Time frame: Immediately after procedure, 0 day
Procedural success is defined as residual stenosis of the target lesion ≤30% (by visual estimation) and TIMI flow grade 3 after PCI.
Time frame: Immediately after procedure, 0 day
The device usage evaluation includes: pushability, support, overall ease of use, device trackability, and radiopacity. There are four grades, ranging from poor to excellent.
Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Adverse events and serious adverse events related to the study device during the study.
Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Occurrence of adverse events and serious adverse events during the study.
Time frame: Immediately after procedure, 0 day
Incidence of device defects.
Contact information is provided by the study sponsor or research team.
BrosMed Medical Co., Ltd
Industry
A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Safety and Efficacy of Coronary Extension Catheter in Percutaneous Coronary Intervention
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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