SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

Running, not enrolling · Not applicable

Conditions studied: Osteo Arthritis Knee, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis, Osteoarthritis

In brief

An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).

Key facts

Study ID

NCT06550024

Run by

CrannMed

People needed

89

Starts

2024-11-28

Expected to finish

2028-10-01

Last updated by the study team

2026-03-18

Who can join

Age: 40 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able and willing to provide written informed consent, and
• Clinical diagnosis of knee OA, and
• Moderate to severe knee pain (WOMAC Pain ≥ 10), and
• Pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and
• Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
• Age ≥ 40 years and < 80 years, and
• Able to comply with all treatments and follow-up visits.

You may not qualify if…

• Severe knee OA (Kellgren-Lawrence grade 4), or
• Current infection of target joint, or
• Life expectancy less than 36 months, or
• Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
• Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
• Prior knee replacement surgery in the target knee, or
• Pain score of >3 NRS on the non-target knee, or
• An acute internal derangement of the target knee, or
• History of uncorrectable coagulopathy, or
• Prior iodinated contrast reaction resulting in anaphylaxis, or
• Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, or planning pregnancy in the following 12 months, or
• Has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or
• Contraindication to MRI, or
• At the discretion of the Principal Investigator

Where it is running

• University of Alabama Medicine — Birmingham, Alabama, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• Advanced Vascular Institute — Panama City, Florida, United States
• IR Centers — Raleigh, North Carolina, United States
• IR Centers — Leesburg, Virginia, United States
• Bokhua Memorial Cardiovascular Center — Tbilisi, Georgia
• Royal Berkshire NHS Foundation Trust — Reading, United Kingdom
• Nano Medical Clinic — Tashkent, Uzbekistan, Uzbekistan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.