Status:
WITHDRAWN
Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
Lead Sponsor:
Andrew Picel
Conditions:
Knee Osteoarthritis
Knee Pain Chronic
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis...
Eligibility Criteria
Inclusion
- Provide informed consent
- Age ≥ 40 years
- Moderate to severe knee pain (VAS \>40 mm)
- Pain refractory to 3 months of conservative treatments, including at least one of the following:
- a. Anti-inflammatory medications
- b. Physical therapy
- c. Intra-articular injections
- Kellgren-Lawrence radiographic grade 1, 2, or 3 disease
- MRI features of active synovitis (synovial thickening and/or enhancement on MRI).
- Ineligibility or refusal of surgical management.
- Local knee tenderness
Exclusion
- Rheumatoid or infectious arthritis
- Advanced lower extremity atherosclerosis that would limit selective angiography
- Local knee infection
- Prior knee surgery (excluding arthroscopic/meniscal interventions)
- Uncorrectable coagulopathy (INR\>1.8, platelets\<50,000/µL)
- Iodine allergy resulting in anaphylaxis
- Chronic renal insufficiency (serum creatinine \>2 mg/dL)
- Life expectancy less than 6 months
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04472091
Start Date
January 15 2025
End Date
November 1 2026
Last Update
February 24 2025
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94305