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COMPLETED Phase 4

Assess the Penumbra System in the Treatment of Acute Stroke

NCT01429350 · View on ClinicalTrials.gov ↗

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

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

9 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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01429350 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Colorado, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01429350?

This trial is sponsored by Penumbra, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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