This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
supports the insertion of the guide wire,exchange of the guide wire and the delivery of contrast media
The Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
The Seventh People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Technical success
Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom.
Time frame: 0 day
Device success
Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal.
Time frame: 0 day
Procedural success
Defined as meeting all the following criteria: 1. After PCI, the final diameter stenosis of the target lesion achieves ≤30%, and the TIMI returns to grade 3; 2. No all-cause death, Q-wave myocardial infarction, stroke, cardiac tamponade, target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) before discharge.
Time frame: 0 - 7 days
Device super-selective angiography (if applicable)
the microcatheter shall deliver the contrast agent to the designated location and develop
Time frame: 0 day
Guide wire exchange supported (if applicable)
successful exchange of the guide wire
Time frame: 0 day
Device Performance Evaluation
The investigators will evaluate the device performance according to the use and operation of the device during the procedure
Time frame: 0 day
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