VISSIT Intracranial Stent Study for Ischemic Therapy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00816166
First received: December 29, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Transient Ischemic Attack
Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)
Drug: Aspirin and Clopidogrel (Medical therapy)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

    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).



Enrollment: 125
Study Start Date: October 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stent Group
Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")
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)
Active Comparator: Medical Therapy Group
Medical therapy alone ("Medical Therapy Group")
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)

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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00816166     History of Changes
Other Study ID Numbers: VISSIT CA-2007-01, G080051
Study First Received: December 29, 2008
Results First Received: April 18, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by Codman & Shurtleff:
Ischemic stroke
Transient Ischemic Attack
Intracranial Stenting

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014