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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

PROST Trial Summary

This study is evaluating whether a device which removes blood clots from the brain is more effective than a device which does not.

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

PROST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2
Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH)
Secondary outcome measures
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

PROST 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
353,439 Total Patients Enrolled
16 Trials studying Stroke
353,239 Patients Enrolled for Stroke
Richardo A Hanel, MDPrincipal InvestigatorBaptist Medical Center Jacksonville

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
pRESET for Occlusive Stroke Treatment
2019. "pRESET for Occlusive Stroke Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03994822.
~62 spots leftby Apr 2025
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