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

Launched by CASE WESTERN RESERVE UNIVERSITY · Oct 31, 2018

Keywords

ClinConnect Summary

The clinical trial titled "REstoring Flow by REvascularization with Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis" is looking at a new treatment for a serious condition called intracranial atherosclerotic stenosis (ICAS), which can lead to strokes. This study aims to assess how safe and effective a specific procedure is that uses a balloon to open narrowed arteries in the brain. Many patients with ICAS currently have very few treatment options, so finding a new method could significantly improve their health and reduce the risk of stroke, which is a major health issue worldwide.

To participate in this trial, individuals must be between the ages of 30 and 90 and have experienced a recent, mild stroke linked to a significant narrowing of certain brain arteries. They should also be able to give their informed consent. Participants will undergo tests to confirm their condition and may receive the balloon treatment as part of the study. This trial is not yet recruiting participants, but it has the potential to pave the way for new therapies that could greatly benefit patients with ICAS.

Gender

ALL

Eligibility criteria

• 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