Tests a balloon procedure to widen narrowed brain arteries
Tests a balloon procedure in adults with narrowed arteries inside the brain.
Plain-language title generated from the registry record
Registry title: REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis
Key facts
- Where
- Cleveland, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 90 years old?
Source: NCT03729817, who can take part
Where in United States
- Case Western Reserve UniversityCleveland, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Case Western Reserve University
- Trial code
- NCT03729817
- Record updated
- 4 November 2025
- Original description
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.Read full original descriptionShow less
VERiTAS-2 REFRESH ICAS (REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis)
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.
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.