EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
NCT07313800 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-02-04
Summary
This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal arterial contributors to migraine. Adults aged 18-60 with refractory migraine despite prior preventive therapies are eligible. The study assesses migraine outcomes over 12 months using patient-reported headache frequency, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality-of-life measures (MSQ v2.1).
Conditions
- Migraine Disorders
- Refractory Migraine
- Chronic Migraine
Interventions
- DEVICE
-
TEMMA Endovascular Treatment
Endovascular treatment targeting meningeal arterial contributors to migraine performed as part of the TEMMA procedure (Targeted Embolization for Migraine Management) using FDA-cleared devices. Procedural techniques and adjunctive assessments are individualized at the discretion of the treating physician and are not standardized within the study.
Sponsors & Collaborators
-
Cortex Neurovascular
lead INDUSTRY
Principal Investigators
-
Dennis Wang, MD · Cortex Neurovascular
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2027-03-01
- Completion
- 2028-03-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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