Trials / Completed
CompletedNCT02578069
First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the NOVA Sirolimus Eluting Stent Versus the Apollo Stent
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 272 (actual)
- Sponsor
- Sino Medical Sciences Technology Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NOVA Intracranial Sirolimus Eluting Stent System | A sirolimus eluting intracranial stent system with polylactic-co-glycolic acid (PLGA) biodegradable drug carrier and electro-grated polybutyl methacrylate (PBMA) base coating. The stent platform is made of 316L stainless steel. |
| DEVICE | Apollo Intracranial Stent System | A 316L stainless steel balloon-expandable intracranial stent system |
Timeline
- Start date
- 2015-04-27
- Primary completion
- 2020-01-01
- Completion
- 2020-01-01
- First posted
- 2015-10-16
- Last updated
- 2021-10-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02578069. Inclusion in this directory is not an endorsement.