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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
For the subjects who met the requirements of the study protocol, the BM coronary extension catheter was used for treatment.
Beijing Friendship Hospital, Capital Medical University
Beijing, China
RECRUITINGDevice Delivery Success Rate
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 Rate
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
Device Usage Evaluation
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: Immediately after procedure, 0 day
Adverse events and serious adverse events related to the study device
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)
Adverse Event and Serious Adverse Event
Occurrence of adverse events and serious adverse events during the study.
Time frame: Endpoints will be measured through hospital discharge (expected to be within 7 days)
Device defects
Incidence of device defects.
Time frame: Immediately after procedure, 0 day
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