NCT05477940

Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System

Exploratory Study on the Safety and Effectiveness of Absorbable Zinc Alloy Drug-eluting Coronary Stent System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shandong Branden Med.Device Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Heart Disease
• Drug Eluting Stent

Interventions

Type	Name	Description
DEVICE	Absorbable zinc alloy drug eluting coronary stent system	Absorbable zinc alloy drug eluting coronary stent system" (hereinafter referred to as "stent system") consists of "delivery system" and "drug stent (hereinafter referred to as stent)" pressed on the balloon end of the delivery system

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2022-07-28
• Last updated: 2022-07-28