Coronary Heart Disease Clinical Trial
Official title:
Exploratory Study on the Safety and Effectiveness of Absorbable Zinc Alloy Drug-eluting Coronary Stent System
This trial is a prospective, two center single group registration pilot trial aiming to evaluate the product safety, and provide information for the later confirmatory test design according to the results.
This trial is a prospective, two center single group registration pilot trial with late lumen loss in stent (LLL), mace event and target lesion failure (TLF) as the main endpoint. Subjects were followed up clinically or by telephone at 1 month, 3 months, 6 months, 9 months and 12 months, and coronary angiography was performed at the target lesion segments for 6 months to calculate lumen loss. Analyze and evaluate the collected data, preliminarily evaluate the product safety, and provide information for the later confirmatory test design according to the results. ;
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