Acute Ischemic Stroke
Conditions
Brief summary
This is a safety study of the Rapid System for acute ischemic stroke.
Interventions
DEVICERapid System
Sponsors
Rapid Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 to \<85 years old * Pre stroke modified Rankin Scale (mRS) of ≤2 * A signed informed consent by patient or a legally acceptable representative
Exclusion criteria
* Pre-stroke life expectancy of less than 6 months * Current participation in another investigational drug or device study * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage | 12 patients |
Countries
Sweden
Outcome results
None listed