To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician.
This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE) post-market study with two cohorts. The primary objective of Cohort I of the RESTORE study is to determine the proportion of subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke in the anterior circulation based on collection of real-world evidence data. Secondary objectives include the evaluation of good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure related major neurological complications, all based on real-world evidence data collected. The objective of Cohort II of the study is to evaluate standard outcomes such as successful revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure related major neurological complications based on real-world evidence data. Additional outcomes may be defined and research questions generated based on review of the collected data.
Study Type
OBSERVATIONAL
Enrollment
710
Patient will be treated with mechanical thrombectomy at the direction of the treating physician
Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment
Time frame: During the procedure
Proportion of subjects with good functional outcome defined as mRS ≤ 2
Time frame: 90 days
Occurrence of procedure related serious adverse events
Time frame: During the procedure through study completion at 90 days
Occurrence of sICH within 24 hours
Time frame: 24 hours post-operative
Occurrence of embolization to new territories (ENT)
Time frame: During the procedure
Presence of vasospasm involving the accessed vascular tree
Time frame: During the procedure through 24 hours post-operative
Mortality at day 90
Time frame: 90 days post-procedure
Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment
Time frame: During the procedure
Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment
Time frame: During the procedure
Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass
Time frame: During the procedure
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Pacific Neuroscience Institute (Providence)
Burbank, California, United States
Mercy San Juan - Dignity Health Research Institute
Carmichael, California, United States
Kaiser Permanente, Northern California
Redwood City, California, United States
UCHealth Memorial
Colorado Springs, Colorado, United States
Memorial Healthcare System
Hollywood, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Javon Bea Hospital
Rockford, Illinois, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
...and 27 more locations
Time from groin puncture to initial contact of clot with aspiration catheter
Time frame: During the procedure
Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment
Time frame: During the procedure
Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation
Time frame: During the procedure