GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Stopped: Dissatisfactory enrollment rate with no safety concerns
United States7 participantsStarted 2021-02-05
Plain-language summary
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is 18-55 years of age at the screening visit.
✓. Subject is willing and capable of complying with the study protocol requirements, including the specified follow-up period, and can be contacted by telephone.
✓. Subject signed an Informed Consent Form prior to study participation.
✓. Subject's symptoms meet International Classification of Headache Disorders - 3 (ICHD-3) Diagnostic Criteria for migraine with or without aura.
✓. Subject has at least one year of migraine symptom duration.
✓. Subject had migraine onset younger than 50 years of age.
✓. Subject has more than one migraine headache day per week on average by history - headache day defined as: headache that meets ICHD-3 criteria for migraine or probable migraine with or without aura and lasts at least four hours or administration of acute medication before four hours (regardless of clinical response to acute medication).
✓. Subject has tried and failed at least two preventive medications at adequate dosage for an adequate duration, in the judgement of the study site neurologist, and be from two separate classifications of the following classes of drugs: antidepressants, antihypertensive, anticonvulsant, onabotulinumtoxin A, CGRP inhibitors or other treatments with at least one positive randomized placebo-controlled trial (See APPENDIX A).
Exclusion criteria
✕. Subject is currently enrolled in any pre-approval investigational study. (Does not apply to long-term post-market studies unless participation might interfere clinically with the RELIEF endpoints.)
What they're measuring
1
Reduction in Migraine Headache Days: mean reduction in the number of migraine headache days per month from baseline to follow-up headache days per month from baseline to follow-up
Timeframe: Week 40
2
Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure
✕. Subject has known organic issues which may cause headaches (e.g., temporo-mandibular joint, brain tumor, cervical spinal issues, known seizure disorder, etc.).
✕. Subjects with hemicrania continua, post-traumatic headache, or other trigeminal autonomic cephalalgia secondary headache disorders.
✕. Subject has known hypersensitivity or contraindication to thienopyridines.
✕. Subject is currently taking a P2Y12 inhibitor (See APPENDIX B).
✕. Subject has need for chronic oral anticoagulation therapy (e.g., atrial fibrillation, mechanical heart valve, etc.) (See APPENDIX B).
✕. Subject has need for chronic antiplatelet therapy.
✕. Subject has need for daily use of non-steroidal anti-inflammatory drugs (NSAIDs) (See APPENDIX B).