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First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial) — NOVA  

Ischemic Stroke Clinical Trial

Official title:
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the NOVA Sirolimus Eluting Stent Versus the Apollo Stent

Clinical Trial Summary

Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.

Clinical Trial Description

The study will enroll 264 subjects overall in two groups (randomized 1:1). The study follow-up will occur at 1, 6 and 12 months post-stent implantation. All patients will undergo angiography assessment (DSA/CTA) at 12 months follow-up. Angiography assessment will be performed at baseline (pre- and post-procedure) and 12 months follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02578069
Study type Interventional
Source Sino Medical Sciences Technology Inc.
Contact
Status Completed
Phase N/A
Start date April 27, 2015
Completion date January 2020
View Details
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