Stroke Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 159 |
Est. completion date | October 31, 2030 |
Est. primary completion date | October 31, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 90 Years |
Eligibility | 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 >90°, 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 |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Western Reserve University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural Safety | Any stroke (ischemic or hemorrhagic), or death, within 30 days following submaximal angioplasty | 30 days | |
Secondary | Clinical Efficacy | Any stroke/death within 30 days or ischemic stroke in the symptomatic vessel territory at one year | 1 year | |
Secondary | Hemodynamic Success | Initial hemodynamic effect of submaximal balloon angioplasty on treated vessel flow | post procedure (within 7 days) | |
Secondary | Hemodynamic Durability | Hemodynamic durability of submaximal balloon angioplasty at follow-up in the treated vessel at follow-up | 1 year |
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