NCT04456569
Geniculate Artery Embolization for Osteoarthritis
Active, Not Recruiting
NAAges 40–70InterventionalTreatmentUniversity of MinnesotaInvestigator-initiated
~20 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Geniculate Artery Embolization
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as Assessed by Grade 3-4 Adverse events
Measured over 12 months
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Reza Talaie, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Between 40 - 70 years of age.
Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude).
Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months).
Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months.
Willing to comply with regular follow up during the 12 month follow-up period.
Not a current candidate for partial or total knee arthroplasty.
WOMAC Score \>=6 in at least 2 categories.
Exclusion
BMI \>35 kg/m2
Advanced peripheral arterial disease (resting ABI \<= 0.9).
Known significant peripheral arterial disease precluding common femoral catheterization
Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
Diabetics with hemoglobin A1C of \>9%
Previous lower extremity embolization
Uncontrolled emotional disorders per patient medical history
Chronic pain syndrome or currently under a pain contract.
Anatomic variants involving the lower extremities which would increase the risk of non-target embolization
Renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis.
Abnormal INR (\>1.5)
Platelet count \<50x109/L.
Currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
Known severe allergy to iodine which cannot be adequately pre-medicated
Pregnant or intend to become pregnant within 6 months of the procedure
Contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
Life expectancy \<60 months
Currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Contraindications to medical and physical rehabilitative treatments of OA.
Advanced atherosclerosis.
Current or previous lower extremity fistula.
Rheumatoid arthritis or seronegative arthropathies.
WOMAC Pain Scale \< 6
Steroid injection in the affected joint within 3 months of screening. I- n investigator assessment, patient is not a candidate for study participation
What this trial measures
- Safety as Assessed by Grade 3-4 Adverse events12 months
Safety will be reported using the combined number of grade 3 and 4 adverse events that occur in each arm.