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NCT01429350 · ClinicalTrials.gov registry record · Phase 4

Assess the Penumbra System in the Treatment of Acute Stroke

A Phase 4 study of Ischemic Stroke, sponsored by Penumbra.

Completed
Registry status
Phase 4
Development phase
108
Enrollment target
4
Study locations

NCT01429350 is a Phase 4 study of Ischemic Stroke that has completed, run by Penumbra. The registered enrollment target is 108 participants, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT01429350, a Phase 4 study of Ischemic Stroke, has completed, sponsored by Penumbra.

COMPLETED
Registry status
Phase 4
Development phase
108 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Conditions Studied

Ischemic Stroke

Interventions

  • DRUG intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
  • DEVICE Penumbra System

Study Locations (4)

Colorado

  • Endovascular Surgical Neuroradiology, Swedish Medical Center - Denver

Florida

  • Department of Neurological Surgery - Gainesville

Illinois

  • Neurosurgery, Rush University Medical Center - Chicago

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2012-05
Est. Completion 2016-10
Phase Phase 4

Sponsor

Penumbra

25 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01429350

The ClinicalTrials.gov registry entry for NCT01429350 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (93% lower). The listed sponsor is Penumbra, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which intravenous (IV) recombinant human tissue plasminogen activator (rtPA) is the first listed.

NCT01429350 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT01429350 about?

NCT01429350 is a clinical study titled "Assess the Penumbra System in the Treatment of Acute Stroke". The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug app...

What is the current status of trial NCT01429350?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2012-05. Estimated completion is 2016-10.

What conditions does trial NCT01429350 study?

This clinical trial studies the following conditions: Ischemic Stroke.

What interventions are being tested in trial NCT01429350?

The interventions under investigation include: intravenous (IV) recombinant human tissue plasminogen activator (rtPA) (DRUG), Penumbra System (DEVICE).

Who is sponsoring clinical trial NCT01429350?

This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01429350 being conducted?

This trial has 4 study locations across Colorado, Florida, Illinois, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.