This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.
The Seventh People's Hospital of Zhengzhou
Zhenzhou, Henan, China
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Procedural Success Rate
Defined as meeting all the following criteria: 1. After PCI, the target lesion achieves a final diameter stenosis of ≤30%, and the TIMI grade of 3; 2. No all-cause mortality, Q-wave myocardial infarction, stroke, cardiac tamponade, or target vessel revascularization (including re-PCI or emergency coronary artery bypass grafting) during postoperative follow-up.
Time frame: 7 days
Device Success Rate
Defined as meeting all the following criteria: 1. Successful delivery to the target location, completely pre-dilatation and successful withdrawal by using Alveo HP Balloon Dilatation Catheter; 2. No evidence of arterial perforation, flow-restricted dissection, decreased TIMI grade while using the device, or no clinically significant arrhythmias after pre-dilatation.
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. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance.
Time frame: 0 day
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