Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-01 @ 6:40 PM
Study NCT ID:
NCT00816166
Status:
TERMINATED
Last Update Posted:
2015-02-20
First Post:
2008-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VISSIT Intracranial Stent Study for Ischemic Therapy
Sponsor:
Codman & Shurtleff
Organization:
Study Overview
Official Title:
Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISSIT
Brief 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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| G080051 | None | None | View |