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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05477940
Study type Interventional
Source Shandong Branden Med.Device Co.,Ltd
Contact
Status Not yet recruiting
Phase N/A
Start date September 1, 2022
Completion date September 1, 2024

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