REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Ather… (NCT03729817) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis
United States159 participantsStarted 2027-10
Plain-language summary
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.
Who can participate
Age range30 Years – 90 Years
SexALL
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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 assessm…