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VERiTAS II REFRESHED

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03729817
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : October 19, 2020
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 hemodynamic compromise identifies a high risk subgroup of patients with symptomatic intracranial atherosclerotic disease. 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 hemodynamically-compromised patients with intracranial atherosclerotic stenosis. The study will also examine as secondary aims, the effect of the intervention on hemodynamics and on subsequent in-territory ischemic events.

Condition or disease Intervention/treatment Phase
Intracranial Atherosclerotic Disease Stroke Device: Submaximal balloon angioplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: subjects will be recruited into a single arm undergoing intervention.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vertebrobasilar Stroke and Risk of Transient Ischemic Attack and Stroke (VERiTAS) II - Restoring Flow by Revascularization With Submaximal Angioplasty in Hemodynamic Intracranial Atherosclerotic Disease (REFRESHED) Study
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : January 31, 2027
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Submaximal balloon angioplasty
Endovascular intervention with submaximal balloon angioplasty
Device: Submaximal balloon angioplasty
An endovascular procedure involving inflation of a balloon catheter undersized to 50-70% of normal vessel diameter to perform angioplasty of a stenotic blood vessel segment, with the goal of increasing blood flow.




Primary Outcome Measures :
  1. Device Safety - based on periprocedural risk of any stroke and death [ Time Frame: 30 days ]
    Any stroke (ischemic or hemorrhagic), or death, within 30 days following submaximal angioplasty


Secondary Outcome Measures :
  1. Clinical Efficacy - based on periprocedural stroke/death and subsequent in-territory stroke [ Time Frame: 1 year ]
    Any stroke/death within 30 days or ischemic stroke in the symptomatic vessel territory at one year

  2. Hemodynamic Success - based on improvement of blood flow on QMRA in the treated vessel [ Time Frame: post procedure (within 7 days) ]
    Initial hemodynamic effect of submaximal balloon angioplasty in the treated vessel measured by ml/min on QMRA

  3. Hemodynamic Durability - based on sustained improvement of blood flow on QMRA in the treated vessel or vascular territory [ Time Frame: 1 year ]
    Hemodynamic durability of submaximal balloon angioplasty at follow-up in the treated vessel or vascular territory measured by ml/min on QMRA



Information from the National Library of Medicine

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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

  • Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (ICA, MCA, VA, BA) - may be diagnosed by MRA, CTA or DSA to qualify for angiogram performed as part of the study, but must be confirmed by catheter angiography for enrollment into the trial
  • Hemodynamic compromise based on borderzone infarct pattern for the anterior circulation (ICA and MCA) and by low flow state on QMRA for the posterior circulation (VA and BA).
  • Target vessel with minimal nominal diameter of 2mm
  • Target length of stenosis <18mm
  • Symptoms within 30 days of enrollment
  • Age 18 and above
  • Able to provide informed consent

Exclusion Criteria:

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

Neurologic:

  • Major disabling stroke 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 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 PUD, 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 or carotid artery tortuosity, stenosis or occlusion prohibiting access to the target lesion (Extracranial disease is not exclusionary if does not prohibit access to 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 NOAC beyond enrollment (e.g. venous thrombo-embolism, atrial fibrillation)
  • Thrombolytic therapy within 24 hours

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


Contacts
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Contact: Sepideh Amin-Hanjani, MD 312-355-2050 hanjani@uic.edu

Locations
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United States, Illinois
University oif Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Sepideh Amin-Hanjani, MD University of Illinois at Chicago
Principal Investigator: Adnan Siddiqui, MD University at Buffalo
Principal Investigator: Tanya Turan, MD Medical University of South Carolina
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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    
Other Study ID Numbers: 2020
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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
Keywords provided by Sepideh Amin-Hanjani, University of Illinois at Chicago:
Intracranial atherosclerotic disease
Stroke
Angioplasty, Balloon
Hemodynamics
Device Safety
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases