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Mechanical Thrombectomy Device

pRESET Thrombectomy Device for Stroke (PROST Trial)

N/A
Waitlist Available
Led By Raul G Nogueira, MD
Research Sponsored by phenox Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 (+/-15) days
Awards & highlights

Summary

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion

Eligible Conditions
  • Stroke
  • Cardiovascular Disease
  • Ischemia
  • Pathology
  • Ischemic Stroke
  • Vascular Disease
  • Brain Diseases
  • Central Nervous System Disorders
  • Nervous System Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 (-8/+12) hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 (-8/+12) hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2
Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
Secondary study objectives
Distribution of mRS shift across the entire spectrum of disability
Cerebrovascular accident
Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: pRESET Thrombectomy DeviceExperimental Treatment1 Intervention
Mechanical Thrombectomy using the pRESET Thrombectomy Device
Group II: Solitaire Revascularization DeviceActive Control1 Intervention
Mechanical Thrombectomy using the Solitaire Revascularization Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mechanical Thrombectomy using the pRESET Thrombectomy device
2019
N/A
~340

Find a Location

Who is running the clinical trial?

phenox Inc.Lead Sponsor
Raul G Nogueira, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center, Pittsburgh
17 Previous Clinical Trials
353,546 Total Patients Enrolled
16 Trials studying Stroke
353,346 Patients Enrolled for Stroke
Richardo A Hanel, MDPrincipal InvestigatorBaptist Medical Center Jacksonville
~57 spots leftby Sep 2025
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