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Mechanical Thrombectomy Device

Cohort I for Stroke ("RESTORE" Trial)

N/A
Recruiting
Led By Dheeraj Gandhi, MBBS, MD
Research Sponsored by Microvention-Terumo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

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.

Eligible Conditions
  • Stroke
  • Vascular Occlusion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

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.

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Who is running the clinical trial?

Microvention-Terumo, Inc.Lead Sponsor
31 Previous Clinical Trials
6,001 Total Patients Enrolled
2 Trials studying Stroke
421 Patients Enrolled for Stroke
Dheeraj Gandhi, MBBS, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
Syed Zaidi, MDPrincipal InvestigatorProMedica Toledo
~219 spots leftby Dec 2025
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