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GORE® CARDIOFORM Septal Occluder Migraine Clinical Study

NCT04100135 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-12-18

No results posted yet for this study

Summary

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Conditions

  • Migraine
  • Patent Foramen Ovale
  • PFO - Patent Foramen Ovale

Interventions

DEVICE

Actual device PFO closure

Actual PFO closure with the GORE® CARDIOFORM Septal Occluder

DRUG

Thienopyridine (clopidogrel or prasugrel)

Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure

DEVICE

Sham device PFO closure

Sham (simulated) device PFO closure with result of no device implantation and no PFO closure

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Robert Sommer, MD · Columbia University

  • David Dodick, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2024-08-15
Completion
2024-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04100135 on ClinicalTrials.gov