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THUNDER: Acute Ischemic Stroke Study with the Penumbra System® Including Thunderbolt™ Aspiration Tubing

NCT05437055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-01-29

No results posted yet for this study

Summary

The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.

Conditions

  • Acute Ischemic Stroke
  • Large Vessel Occlusion

Interventions

DEVICE

Mechanical Thrombectomy (Penumbra System with Thunderbolt)

Subject will receive Penumbra System with Thunderbolt

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Donald Frei, M.D. · HCA HealthONE, LLC (Swedish Medical Center)

  • David Fiorella, M.D. · The Research Foundation for The State University of New York (Stony Brook University)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-11
Primary Completion
2024-09-23
Completion
2024-12-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05437055 on ClinicalTrials.gov