REperfusion With Cooling in CerebraL Acute IscheMia II
- Conditions
- Ischemic Stroke
- Registration Number
- NCT03804060
- Lead Sponsor
- ZOLL Circulation, Inc., USA
- Brief Summary
The primary objective of this study is to determine the feasibility and safety of achieving rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for patients experiencing acute ischemic stroke due to a large vessel occlusion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Test Arm patients achieving target temperature 1 hour after thrombectomy Percentage of Test Arm patients achieving target temperature \< 34 ºC within 1 hour of arterial puncture for thrombectomy
Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization 36 hours Rate of hemorrhagic conversion
Mean door-to-Recanalization time perioperative door-to-Recanalization time
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
WellStar Kennestone Regional Medical Center
🇺🇸Marietta, Georgia, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Henry Ford
🇺🇸Detroit, Michigan, United States
ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
Mercy Health
🇺🇸Toledo, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
WellStar Kennestone Regional Medical Center🇺🇸Marietta, Georgia, United States