This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants may be given access to the NIH StrokeNet infrastructure. Following peer review, NINDS will prioritize trials among the highest scoring to be given access to the StrokeNet infrastructure. The StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently. The StrokeNet National Data Management Center (NDMC) will provide statistical and data management support. The Regional Coordinating Centers (RCCs) of the StrokeNet and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The StrokeNet network will also be uniquely poised to collaborate with the NINDS Neurological Emergencies Treatment Trials Network (NETT) and/or other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.