Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Study Purpose

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 with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provide informed consent. 2. Age ≥ 40 years. 3. Moderate to severe knee pain (VAS >40 mm) 4. 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. 5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease. 6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI). 7. Ineligibility or refusal of surgical management. 8. Local knee tenderness.

Exclusion Criteria:

1. Rheumatoid or infectious arthritis. 2. Advanced lower extremity atherosclerosis that would limit selective angiography. 3. Local knee infection. 4. Prior knee surgery (excluding arthroscopic/meniscal interventions) 5. Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL) 6. Iodine allergy resulting in anaphylaxis. 7. Chronic renal insufficiency (serum creatinine >2 mg/dL) 8. Life expectancy less than 6 months

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04472091
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Andrew Picel
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrew C Picel, MD
Principal Investigator Affiliation	Stanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Knee Arthritis, Arterial Occlusion

Arms & Interventions

Arms

Experimental: Genicular artery embolization

Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

Interventions

Device: - Genicular artery embolization (GAE)

Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Palo Alto, California

Status

Recruiting

Address

Stanford University

Palo Alto, California, 94305

Site Contact

Andrew C Picel, MD

[email protected]

650-736-6109

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