Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT04456569
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04456569
Study Brief:
Protocol Section:
NCT04456569