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

Active, not recruiting

Phase 2/3 Results N/A

Trial Description

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

  • NOVA Intracranial Sirolimus Eluting Stent System Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Experimental
    Description: NOVA Intracranial sirolimus eluting stent system
  • Apollo Intracranial Stent System Device
    Intervention Desc: A 316L stainless steel balloon-expandable intracranial stent system
    ARM 1: Kind: Experimental
    Label: Control
    Description: Apollo Intracranial stent system

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary In stent restenosis rate (> 50% restenosis) 12 months post-procedure No
Secondary Stroke and death events within 30 days after stenting Yes
Secondary Target vessel ischemic stroke event between 30 days and 1 year post-procedure Yes
Secondary Acute procedural success rate (stenosis < 30%) 1 year No
Secondary Target vessel stroke or death events within 30 days after stenting Yes
Secondary Non-target vessels ischemic stroke event between 30 days and 1 year post-procedure Yes
Secondary Recurrent ischemic stroke in the involved vascular area between 30 days and 1 year post-procedure Yes
Secondary Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events between 30 days and 1 year post-procedure Yes
Secondary Death event between 30 days and 1 year post-procedure Yes
Secondary Transient ischemic attack event within 1 year post-procedure Yes
Secondary National Institutes of Health Stroke Scale (NIHSS) evaluation at 1 and 12 months Yes
Secondary modulate RANK score (mRS)evaluation at 1 and 12 months Yes
Secondary Montreal Cognitive Assessment (MoCA) evaluation at 1 and 12 months Yes
Secondary EQ-5D score evaluation at 12 months Yes

Sponsors