VISSIT Intracranial Stent Study for Ischemic Therapy "VISSIT"

Terminated

Phase 2/3 Results

Trial Description

The main objective of this study is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial.
A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.

Detailed Description

1.1 Study Hypothesis Treatment of cerebral or retinal ischemia due to plaque in the neurovasculature using the PHAROS Vitesse Stent System plus medical therapy will provide additional clinical benefit over medical therapy alone.
1.2 Primary Effectiveness Endpoint
The primary effectiveness endpoint consists of a composite of the two following outcomes:
- Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization
- Hard TIA in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
1.3 Safety Outcomes
Safety outcomes to be collected and reported as part of the overall risk-to-benefit profile for this device are:
- Stroke in any territory within 30 days of randomization
- Death from any cause within 30 days of randomization
- Hard TIA in any territory occurring after a 24 hour post-procedure stabilization period (days 2-30) since the recovery from anesthesia can mask accurate assessment of possible TIA symptoms.
- Intracranial hemorrhage within 30 days of randomization
1.4 Other Outcomes
- Stent Success - PHAROS Vitesse stent deployed across target lesion with residual stenosis 0-20%
- Percentage of Stent Group Subjects with any (symptomatic or asymptomatic) in-stent restenosis ≥ 70% confirmed by angiogram at 12 months
- Percentage of Stent Group Subjects with symptomatic in-stent restenosis ≥ 70% confirmed by angiogram at 12 months
- Percentage of Medical Therapy Group Subjects with interventional procedure (e.g., angioplasty or stent) at 12 months
- Comparison of NIHSS scores between treatment arms
- Comparison of mRS scores between treatment arms

Conditions

Interventions

  • Pharos Vitesse Neurovascular Stent System (Stent implantation) Device
    Other Names: Pharos Vitesse Neurovascular Stent System
    Intervention Desc: Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions.
    ARM 1: Kind: Experimental
    Label: Stent Group
    Description: Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
  • Aspirin and Clopidogrel (Medical therapy) Drug
    Other Names: Aspirin; Clopidogrel; Plavix(r)
    Intervention Desc: Medical therapy alone [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)]
    ARM 1: Kind: Experimental
    Label: Medical Therapy Group
    Description: Medical therapy alone ("Medical Therapy Group")
  • Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) Device
    Other Names: Pharos Vitesse Neurovascular Stent System; Asprin; Clopidogrel; Plavix(r)
    Intervention Desc: Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions + Medical therapy [Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)]
    ARM 1: Kind: Experimental
    Label: Stent Group
    Description: Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary To determine whether intracranial stenting with the Pharos Vitesse Neurovascular Stent System with best medical therapy is superior to best medical therapy alone in treatment of high-risk patients with ischemic disease. Two Years Yes
Secondary A secondary objective of this study is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs. Three years No
Primary Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months One Year Yes

Sponsors