NCT05692882

A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China

To Evaluate the Safety and Efficacy of the NOVA Intracranial Drug-eluting Stent System in "real World" Patients with Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Post-marketing Registry Clinical Study (NOVA II)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Sino Medical Sciences Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate the long-term safety and efficacy of the NOVA intracranial drug-eluting stent system in "real world" patients with intracranial atherosclerotic stenosis.

Detailed description

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from December 2022 to December 2030 with 1000 subjects recruited in around 50 Chinese centers. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, operation date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary outcome was a composite of stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.

Conditions

• Intracranial Arteriosclerosis
• Stenosis Artery
• Drug-Eluting Stents
• Intracranial Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Drug-Eluting Stents	The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

Timeline

• Start date: 2023-11-16
• Primary completion: 2025-12-30
• Completion: 2029-12-30
• First posted: 2023-01-20
• Last updated: 2025-04-01

Locations

5 sites across 1 country: China