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COMPLETED NA

GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients

NCT00738894 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA. A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.

Interventions

  • DEVICE Septal Occluder Device
  • DRUG Antiplatelet Medical Therapy

Study Locations (2)

Pennsylvania

  • University of Pennsylvania Medical Center — Philadelphia

Other

  • Rigshospitalet — Copenhagen

Trial Details

FieldValue
Enrollment Target 664 participants
Start Date 2008-12-10
Est. Completion 2020-05-11
Phase NA

Sponsor

W.L.Gore & Associates

117 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00738894

The ClinicalTrials.gov registry entry for NCT00738894 describes a study currently listed as completed. It is categorized as NA, 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 664 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions — of which Septal Occluder Device 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: NCT00738894 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Other. 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 NCT00738894 about?

NCT00738894 is a clinical study titled "GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients". The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TI...

What is the current status of trial NCT00738894?

This trial is currently completed. It is a NA study. The enrollment target is 664 participants. The study started on 2008-12-10. Estimated completion is 2020-05-11.

What conditions does trial NCT00738894 study?

This clinical trial studies the following conditions: Stroke, Transient Ischemic Attack. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00738894?

The interventions under investigation include: Septal Occluder Device (DEVICE), Antiplatelet Medical Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00738894?

This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00738894 being conducted?

This trial has 2 study locations across Pennsylvania. 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