VERiTAS-2 REFRESH ICAS (REstoring Flow by REvascularization With Submaximal Angioplasty in Hemodynamic IntraCranial Atherosclerotic Stenosis)
Case Western Reserve University
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.
Description
VERiTAS II REFRESH ICAS is a prospective single-arm multi-center pilot study to assess the safety of submaximal balloon angioplasty in conjunction with intensive medical therapy in patients with hemodynamically-compromised symptomatic 70-99% atherosclerotic intracranial stenosis (ICAS). This study builds on lines of evidence from prior prospective studies that established the markedly elevated risk of subsequent stroke in ICAS patients with hemodynamic compromise, and preliminary data from small case series that support submaximal angioplasty as a potentially safe option for revascularization.…
Eligibility
- Age range
- 30–90 years
- Sex
- All
- Healthy volunteers
- No
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 * Sympto…
Interventions
- DeviceSubmaximal balloon angioplasty
An endovascular procedure involving inflation of a balloon catheter undersized to 50-75% of normal vessel diameter to perform angioplasty of a stenotic blood vessel segment, with the goal of increasing blood flow.
Location
- Case Western Reserve UniversityCleveland, Ohio