VISSIT Intracranial Stent Study for Ischemic Therapy

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00816166
Study type	Interventional
Source	Codman & Shurtleff
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	October 2008
Completion date	June 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

VISSIT Intracranial Stent Study for Ischemic Therapy — VISSIT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms