REal-World Analyses of Stroke - Thrombus Occlusion REtrieval
("RESTORE" Trial)
Recruiting at 38 trial locations
SW
OS
MS
OS
MW
Overseen ByMichelle Wetherby
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Microvention-Terumo, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Research Team
DG
Dheeraj Gandhi, MBBS, MD
Principal Investigator
University of Maryland, Baltimore
SZ
Syed Zaidi, MD
Principal Investigator
ProMedica Toledo
Eligibility Criteria
Inclusion Criteria
The patient had a NIHSS score of 5 or greater at the time of intervention.
You must present with symptoms within 8 hours of a groin puncture being administered.
The treating physician has decided to use direct aspiration as the initial treatment method and device before study enrollment, independent of the RESTORE research.
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Treatment Details
Interventions
- Gomco 405 Aspiration Pump
- MicroVention Mechanical Thrombectomy Devices
- MicroVentionTubing Kit
- SOFIA® Flow Plus 6F Aspiration Catheter
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Cohort IIExperimental Treatment1 Intervention
Cohort II will focus on data collection on MicroVention devices used for acute ischemic stroke treatment with the intent to evaluate standard outcomes while also generating additional research questions for analysis based on data collected.
Group II: Cohort IExperimental Treatment1 Intervention
Cohort I will focus on data collection on the SOFIA® Flow Plus 6F Aspiration Catheter used with the direct aspiration as first line treatment technique with the intent to evaluate per prespecified endpoints.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Microvention-Terumo, Inc.
Lead Sponsor
Trials
32
Recruited
7,000+
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