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NCT03729817Not yet recruiting

REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis

VERiTAS-2 REFRESH ICAS (REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis)

Source: ClinicalTrials.gov · Last updated 4 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

By assessing the safety and durability of an endovascular intervention, this study will justify and inform the design of a subsequent seamless feasibility/pivotal trial aimed at the treatment of intracranial atherosclerotic stenosis (ICAS), an entity which carries a high risk of stroke despite existing medical therapies, and has no other treatment options. Given the global burden of ICAS as a leading cause of stroke, there is a high potential for public health impact not just in the U.S., but world-wide.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
159 (estimated)
First submitted
16 Oct 2018
Start date
Oct 2027
Primary completion date
31 Oct 2031
Lead sponsor
Case Western Reserve University
Diseases
Stroke
NCT number
NCT03729817

What you commit to

  • Study type: Interventional
  • Planned participants: 159
  • From Oct 2027 to the primary completion date, 31 Oct 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Inclusion:
  • Non-severe recent stroke (within 30 days) attributed to 70-99% stenosis of intracranial artery (internal carotid, middle cerebral, vertebral, basilar); must be confirmed by CTA (or DSA if already available) for enrollment into the trial.
  • Hemodynamic compromise based on borderzone infarct pattern\* for the anterior circulation (internal carotid and middle cerebral artery stenosis) and by low flow state on QMRA\*\* for the posterior circulation (vertebral and basilar artery stenosis).
  • Target vessel with minimal nominal diameter of 2mm
  • Target length of stenosis \<18mm
  • Symptoms within 30 days of enrollment
  • Age ≥30 and ≤90 years old#
  • Able to provide informed consent
    • \*Sole or predominant borderzone infarct pattern of qualifying event, as defined by SAMMPRIS cohort analysis \*\*Low flow state as determined by optimized flow algorithm as defined by the VERiTAS Study
    • #Those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).
    • Exclusion:
  • 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
  • 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)
  • 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 (not exclusionary if does not prohibit access to target lesion)
  • 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

Age in the registry: 30 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Case Western Reserve University
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.