VISSIT Intracranial Stent Study for Ischemic Therapy

NCT00816166 | Terminated Phase 2 Results DMC

• 2 other identifiers: VISSIT CA-2007-01G080051
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Keywords

Ischemic stroke; Transient Ischemic Attack; Intracranial Stenting

Outcome Measures

Primary Outcomes (1)

• Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months

  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).

  One Year

Study Arms (2)

Stent Group

EXPERIMENTAL

Medical therapy + PHAROS Vitesse neurovascular stent ("Stent Group")

Device: Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel)

Medical Therapy Group

ACTIVE COMPARATOR

Medical therapy alone ("Medical Therapy Group")

Drug: Aspirin and Clopidogrel (Medical therapy)

Interventions

Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel) DEVICE

Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions + Medical therapy \[Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)\]

Also known as: Pharos Vitesse Neurovascular Stent System, Asprin, Clopidogrel, Plavix(r)

Stent Group

Aspirin and Clopidogrel (Medical therapy) DRUG

Medical therapy alone \[Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)\]

Also known as: Aspirin, Clopidogrel, Plavix(r)

Medical Therapy Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Subject has normal artery adjacent to each stenosis; diameter 2.0 mm - 5.0 mm
• Subject age is 18-85 years
• Life expectancy is at least 2 years
• Subject 's mRS score is ≤ 3
• Subject is available for study follow-up visits (e.g., lives within 3 hours of research center)
• 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)

You may not qualify if:

• 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
• 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)
• Subject has a previous stent in the territory of the target lesion(s)
• Subject has a previous coil or clip placed in the territory of the target lesion within 6 months
• 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)
• Subject has concurrent intracranial pathology, e.g.
• Moyamoya
• Vasculitis documented by biopsy results

Sponsors & Collaborators

• Codman & Shurtleff: lead

Related Publications (7)

• Berkefeld J, Hamann GF, du Mesnil R, Kurre W, Steinmetz H, Zanella FE, Sitzer M. [Endovascular treatment for intracranial stenoses. A common statement by neurologists and neuroradiologists]. Nervenarzt. 2006 Dec;77(12):1444-55. doi: 10.1007/s00115-006-2182-z. German.

  PMID: 17119891 BACKGROUND

• Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.

  PMID: 15800226 BACKGROUND

• Cruz-Flores S, Diamond AL. Angioplasty for intracranial artery stenosis. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004133. doi: 10.1002/14651858.CD004133.pub2.

  PMID: 16856032 BACKGROUND

• Derdeyn CP, Chimowitz MI. Angioplasty and stenting for atherosclerotic intracranial stenosis: rationale for a randomized clinical trial. Neuroimaging Clin N Am. 2007 Aug;17(3):355-63, viii-ix. doi: 10.1016/j.nic.2007.05.001.

  PMID: 17826637 BACKGROUND

• Fiorella D, Chow MM, Anderson M, Woo H, Rasmussen PA, Masaryk TJ. A 7-year experience with balloon-mounted coronary stents for the treatment of symptomatic vertebrobasilar intracranial atheromatous disease. Neurosurgery. 2007 Aug;61(2):236-42; discussion 242-3. doi: 10.1227/01.NEU.0000255521.42579.31.

  PMID: 17762735 BACKGROUND

• Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. doi: 10.1161/STROKEAHA.107.482752. Epub 2007 Jun 21. No abstract available.

  PMID: 17585085 BACKGROUND

• Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693.

  PMID: 25803346 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Early termination of enrollment led to small numbers of subjects analyzed (less than 50% of the prospectively planned sample size). Various endpoints, subgroup and sensitivity analyses were not conducted because the study was not fully enrolled.

Results Point of Contact

• Title: Jonathan Megerian, MD PhD
• Organization: Codman Neuro

jmegeri1@its.jnj.com

508-880-8274

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 31, 2008
• Study Start: October 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 20, 2015
• Results First Posted: June 16, 2014

Record last verified: 2015-02