pRESET for Occlusive Stroke Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Brain Diseases
- Cardiovascular Diseases
- Central Nervous System Diseases
- Cerebrovascular Disorders
- Ischemia
- Nervous System Diseases
- Pathologic Processes
- Stroke Acute
- Stroke Ischemic
- Vascular Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective, multi-center randomizedMasking: Single (Outcomes Assessor)Masking Description: The blinded assessor performs all study assessments during and after hospital discharge (i.e., 24 hours, Day 7/Discharge (whichever is earlier), and 30 and day 90 visitsPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revasculariza...
To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device
Tracking Information
- NCT #
- NCT03994822
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Raul G Nogueira, MD Grady Memorial Hospital Principal Investigator: Richardo A Hanel, MD Baptist Medical Center, Jacksonville
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