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VISSIT Intracranial Stent Study for Ischemic Therapy (VISSIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00816166
Recruitment Status : Terminated
First Posted : December 31, 2008
Results First Posted : June 16, 2014
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

Tracking Information
First Submitted Date  ICMJE December 29, 2008
First Posted Date  ICMJE December 31, 2008
Results First Submitted Date  ICMJE April 18, 2014
Results First Posted Date  ICMJE June 16, 2014
Last Update Posted Date February 20, 2015
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months [ Time Frame: One Year ]
The primary effectiveness endpoint was 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 Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization
A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months).
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2008)
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. [ Time Frame: Two Years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2008)
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. [ Time Frame: Three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VISSIT Intracranial Stent Study for Ischemic Therapy
Official Title  ICMJE Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease
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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Stroke
  • Transient Ischemic Attack
Intervention  ICMJE
  • Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)
    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)]
    Other Names:
    • Pharos Vitesse Neurovascular Stent System
    • Asprin
    • Clopidogrel
    • Plavix(r)
  • Drug: Aspirin and Clopidogrel (Medical therapy)
    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)]
    Other Names:
    • Aspirin
    • Clopidogrel
    • Plavix(r)
Study Arms  ICMJE
  • Experimental: Stent Group
    Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
    Intervention: Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)
  • Active Comparator: Medical Therapy Group
    Medical therapy alone ("Medical Therapy Group")
    Intervention: Drug: Aspirin and Clopidogrel (Medical therapy)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
125
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2008)
250
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has at least one neurovascular lesion (70-99%) stenosis [internal carotid, middle cerebral, vertebral artery (C4-BA), and/or basilar artery] symptomatic with a hard TIA or stroke attributable to the territory of the lesion within the past 30 days. An intracranial tandem lesion (50-99%) stenosis may be treated if normal artery segment is sufficient length to avoid overlapping stents.
  2. Target vessel diameter / lesion length measurements are within one of the below per angiogram:

    • Vessel diameter is ≥ 2.0 mm and < 2.5 mm / lesion length is ≤ 16 mm, or
    • Vessel diameter is ≥ 2.5 mm and < 3.0 mm / lesion length is ≤ 18 mm, or
    • Vessel diameter is ≥ 3.0 mm and < 4.5 mm / lesion length is ≤ 26 mm, or
    • Vessel diameter is ≥ 4.5 mm and ≤ 5.0 mm / lesion length is ≤ 31 mm
  3. Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
  4. Subject age is 18-85 years
  5. Life expectancy is at least 2 years
  6. Subject 's mRS score is ≤ 3
  7. Subject is available for study follow-up visits (e.g., lives within 3 hours of research center)
  8. Subject is willing and cognitively able to provide Informed Consent (consent may be indicated verbally and signed by neutral witness if stroke has impaired hand or visual function)

Exclusion Criteria:

  1. Subject has contraindications for balloon expandable stent, e.g.

    • Extreme tortuosity at, or proximal to, target lesion,
    • More than 2 lesions with > 50% stenosis (including vertebral ostia and common carotid disease),
    • Carotid or vertebral dissection
  2. CT scan or MRI evidence of any of the following:

    • Intracranial hemorrhage of type PH1 or PH2
    • Subdural or epidural hemorrhage
    • Mass effect, or
    • Intracranial tumor (except small meningioma)
  3. Subject has a previous stent in the territory of the target lesion(s)
  4. Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
  5. Subject has a potential source of cardiac embolism requiring anticoagulation therapy (e.g., atrial fibrillation, intracardiac thrombus or vegetation, significant mitral stenosis, mechanical heart valve, congestive heart failure with EF <30%, or endocarditis)
  6. Subject has concurrent intracranial pathology, e.g.

    • Moyamoya
    • Vasculitis documented by biopsy results
    • Ruptured Aneurysm
    • Unruptured aneurysm > 7mm
  7. Subject has uncontrolled hypertension (systolic >185 mmHg or diastolic >110 mmHg)
  8. Hemoglobin < 10 g/dL; platelet count < 100,000; or INR > 1.5 (e.g., use of warfarin)
  9. Subject has an uncorrectable bleeding diathesis
  10. Subject's neurological status is unstable and rapidly declining (NIHSS score increased > 4 points within 48 hours prior to randomization)
  11. Subject has a contraindication for combination antithrombotic treatment (e.g., clopidogrel and aspirin) such as peptic ulcer disease
  12. Subject history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
  13. Subject has a known history contraindicating contrast dye or iodine (vs. sensitivity which can be safely controlled by antihistamine, steroid, etc.)
  14. Subject is pregnant or plans to become pregnant in the next 12 months
  15. Myocardial infarction within past 3 months
  16. Treatment with tPA or other thrombolytic agent within 48 hours prior to randomization
  17. Major surgery or trauma within 2 weeks prior to randomization
  18. Enrollment in another investigational device or drug study that may confound the results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00816166
Other Study ID Numbers  ICMJE VISSIT CA-2007-01
G080051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Codman & Shurtleff
Study Sponsor  ICMJE Codman & Shurtleff
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Codman & Shurtleff
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP