Neuro-Interventional Clinical Trials
The Capillary Index Score (CIS) Trial (PI: Sten Solander)
Purpose: The hypothesis, or idea being tested, is that as long as patients have a favorable Capillary Index Score (CIS) they can be successfully treated with Intra-arterial Treatment (IAT) out to 8 hours, as opposed to the standard of care 6 hours, post onset of symptoms. For patients with poor CIS, success rates will be relatively low, with no benefit provided by IAT.
Participants: The population for the study will be patients with anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1) within 8 hours of onset of symptoms. Typically, IAT is only offered to patients up to 6 hours, with no treatment options directly targeting the clot available after that time.
Procedures (methods): The study will be performed prospectively in up to 6 stroke centers, with Akron General Medical Center being the primary institution. Recruitment will happen within the VIR clinic following diagnostic cerebral angiography that determines eligibility of stroke patients. Consent for study treatment may be provided by family or designated caregiver as patients are typically mentally impaired. The study will be carried out in 2 phases. Current study (Phase I)- both patients with favorable CIS (fCIS) and poor CIS (pCIS) will be enrolled to compare outcome of treatment of clots up to 8 hours. 54 patients will be enrolled. A second study (Phase II)- a second study (Phase 2) will be pursued if the primary hypothesis of the current study (Phase I) is supported. A separate application will be submitted to the IRB for the second study if this occurs.