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Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke II (VERiTASII)

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ClinicalTrials.gov Identifier: NCT03729817
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Sepideh Amin-Hanjani, University of Illinois at Chicago

Brief Summary:
Recent prospective observational data has established that distal blood flow compromise measured using noninvasive quantitative magnetic resonance angiography (QMRA) identifies a high risk subgroup of patients with symptomatic atherosclerotic vertebrobasilar (VB) steno-occlusive disease, serving as an imaging biomarker for future stroke risk. The currently proposed study aims to determine if an endovascular intervention, submaximal balloon angioplasty, can be performed with adequate safety in this high risk subgroup of flow-compromised patients with VB stenosis. The study will also examine as secondary aims, the effect of the intervention on distal flow augmentation and on subsequent posterior circulation ischemic events.

Condition or disease Intervention/treatment Phase
Vertebrobasilar Insufficiency Stroke Cerebral Arterial Diseases Device: Submaximal ballon angioplasty Not Applicable

Detailed Description:

The objective is to conduct a multicenter safety study of submaximal balloon angioplasty and intensive medical management in patients with symptomatic VB stenosis associated with distal flow compromise as demonstrated by QMRA. These objectives will be met by enrolling patients into a single arm design of angioplasty and intensive medical therapy.

Primary Objective

1. Determine the safety of submaximal balloon angioplasty for treatment of symptomatic intracranial vertebrobasilar stenosis with distal flow compromise (device safety)

Secondary Objectives

  1. A. Evaluate the initial hemodynamic effect of submaximal balloon angioplasty for symptomatic intracranial vertebrobasilar stenosis with distal flow compromise (evidence of short term biomarker modification) B. Evaluate the hemodynamic durability of submaximal balloon angioplasty at one year (evidence of sustained biomarker modification)
  2. Estimate the risk of subsequent posterior circulation stroke (at one year) following submaximal balloon angioplasty for distal flow compromised symptomatic intracranial vertebrobasilar stenosis (preliminary clinical efficacy)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Intervention Model Description: subjects will be recruited into a single arm undergoing intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke II (VERiTASII)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: Submaximal balloon angioplasty
Endovascular intervention with submaximal balloon angioplasty
Device: Submaximal ballon angioplasty
Submaximal angioplasty involves use of a endovascular balloon to perform angioplasty for vessel stenosis with the aim of reducing, but not fully correcting, the stenosis.




Primary Outcome Measures :
  1. Periprocedural stroke and death [ Time Frame: post-procedure within 30 days ]
    Any stroke (ischemic or hemorrhagic) or death (from any cause) in the periprocedural (30 day) period as an indication of device safety


Secondary Outcome Measures :
  1. Hemodynamic effect of submaximal angioplasty [ Time Frame: post-procedure within 7 days ]
    Initial hemodynamic success of the procedure indicated by improvement of flow status from low to normal

  2. Hemodynamics durability of submaximal angioplasty [ Time Frame: 12 and 24 months post-procedure ]
    Sustained hemodynamic success of the procedure

  3. Subsequent posterior circulation stroke [ Time Frame: 12 months post-procedure ]
    Estimate the risk of subsequent posterior circulation stroke (at one year) following submaximal balloon angioplasty for distal flow compromised symptomatic intracranial vertebrobasilar stenosis (preliminary clinical efficacy).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants must meet all inclusion criteria for enrollment into the study

  • Transient ischemic attack (TIA) or non-severe stroke attributed to 50-99% stenosis of intracranial vertebral or basilar artery*
  • Distal flow compromise based on QMRA blood flow measurements (designation as 'low flow')
  • Target vessel with minimal nominal diameter of 2mm
  • Target length of stenosis <18mm
  • Symptoms within 60 days of enrollment
  • Age 18 and above
  • Able to provide informed consent

    • May be diagnosed by magnetic resonance angiography (MRA), computed tomographic angiography (CTA) or digital subtraction angiography (DSA) to qualify for angiogram performed as part of the study, but must be confirmed by catheter angiography for enrollment into the trial.

Note: Tandem disease eligible for treatment as long as both lesions meet criteria to be treated (e.g. each stenosis <18mm length). For bilateral vertebral stenosis, all accessible eligible lesions will be eligible for treatment.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from study participation Neurologic:

  • Major disabling stroke modified Rankin Score (mRS) >3; progressive or fluctuating deficit within 24 hours
  • Hemorrhagic infarction (based on CT) within 14 days of enrollment
  • Any large stroke (>5cm) to be at risk for hemorrhagic conversion

Medical:

  • Any neurological disease which would confound follow-up assessment
  • Any co-morbid disease condition with <12 month life expectancy
  • Known cardiac disease associated with elevated cardioembolic risk, specifically, atrial fibrillation, prosthetic valve, endocarditis, left atrial/ventricular thrombus, cardiomyopathy with ejection fraction (EF) <25%, cardiac myxoma
  • Blood dyscrasias, specifically polycythemia vera, essential thrombocytosis, sickle cell disease
  • Active bleeding diathesis, h/o major systemic hemorrhage within 30 days, active peptic ulcer disease, platelets<100K (severe liver impairment (AST or ALT>3 x normal, cirrhosis)

Target lesion:

  • Non-atherosclerotic stenosis including dissection, fibromuscular dysplasia, vasculitis, radiation induced vasculopathy, suspected recanalized embolus, suspected vasospastic process
  • Mori C classification of stenosis(i.e. diffuse lesion, extremely angulated >90⁰, excessive proximal tortuosity)Previous treatment of target lesion with stent, angioplasty or other mechanical device
  • Extracranial vertebral artery tortuosity, stenosis or occlusion prohibiting access to the target lesion*

Participant:

  • Unable or unwilling to undergo MRI
  • Unable to undergo cerebral angiography
  • Pregnancy
  • Concurrent participation in another study which would conflict with the current study
  • Allergy or contraindication to aspirin or Plavix
  • Indication for warfarin or novel oral anticoagulant (NOAC) beyond enrollment (e.g. venous thrombo-embolism, atrial fibrillation)
  • Thrombolytic therapy within 24 hours *Extracranial disease is not exclusionary if does not prohibit access to target lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729817


Locations
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United States, Illinois
University oif Illinois at Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Sepideh Amin-Hanjani, MD    312-996-4842    hanjani@uic.edu   
Contact: Linda Rose-Finnell, MPA, CCRA    312-996-4842    lfinnell@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Neurological Disorders and Stroke (NINDS)

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Responsible Party: Sepideh Amin-Hanjani, Professor, Department of Neurosurgery, University of Illinois at Chicago, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03729817     History of Changes
Other Study ID Numbers: 2018
GRANT12668292 ( Other Grant/Funding Number: NIH )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Sepideh Amin-Hanjani, University of Illinois at Chicago:
Vertebrobasilar stenosis
Stenosis
Angioplasty
Blood Flow
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Cerebral Arterial Diseases
Vertebrobasilar Insufficiency
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Intracranial Arterial Diseases