SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

Last updated: March 16, 2026
Sponsor: CrannMed
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Osteoarthritis

Connective Tissue Diseases

Lupus

Treatment

Corticosteroid Injection

SakuraBead Resorbable Microspheres

Clinical Study ID

NCT06550024
CI570
  • Ages 40-79
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject is able and willing to provide written informed consent, and

  2. Clinical diagnosis of knee OA, and

  3. Moderate to severe knee pain (WOMAC Pain ≥ 10), and

  4. Pain refractory to at least 3 months of conservative therapies (anti-inflammatorydrugs, or physical therapy, or intra-articular injections), and

  5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and

  6. Age ≥ 40 years and < 80 years, and

  7. Able to comply with all treatments and follow-up visits.

Exclusion

Exclusion Criteria:

  1. Severe knee OA (Kellgren-Lawrence grade 4), or

  2. Current infection of target joint, or

  3. Life expectancy less than 36 months, or

  4. Known advanced atherosclerosis as defined by history of lower extremity or pelvisarterial bypass graft, lower extremity or pelvis arterial stent placement or priorhistory of vascular claudication, or

  5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or

  6. Prior knee replacement surgery in the target knee, or

  7. Pain score of >3 NRS on the non-target knee, or

  8. An acute internal derangement of the target knee, or

  9. History of uncorrectable coagulopathy, or

  10. Prior iodinated contrast reaction resulting in anaphylaxis, or

  11. Active pregnancy as demonstrated by urine or serum β-hCG, or lactating female, orplanning pregnancy in the following 12 months, or

  12. Has undergone an invasive treatment (including but not limited to: corticosteroidinjection, hyaluronic acid injections, nerve ablation) in the target knee within thepast 3 months, or

  13. Contraindication to MRI, or

  14. At the discretion of the Principal Investigator

Study Design

Total Participants: 89
Treatment Group(s): 2
Primary Treatment: Corticosteroid Injection
Phase:
Study Start date:
November 28, 2024
Estimated Completion Date:
October 31, 2028

Study Description

To compare safety and efficacy of SakuraBead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.

Connect with a study center

  • Bokhua Memorial Cardiovascular Center

    Tbilisi,
    Georgia

    Site Not Available

  • Bokhua Memorial Cardiovascular Center

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN
    United Kingdom

    Site Not Available

  • Royal Berkshire NHS Foundation Trust

    Reading 2639577, RG1 5AN
    United Kingdom

    Site Not Available

  • University of Alabama Medicine

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama Medicine

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Harbor UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • Harbor UCLA Medical Center

    Torrance 5403022, California 5332921 90502
    United States

    Site Not Available

  • Advanced Vascular Institute

    Panama City, Florida 32405
    United States

    Site Not Available

  • Advanced Vascular Institute

    Panama City 4167694, Florida 4155751 32405
    United States

    Site Not Available

  • IR Centers

    Raleigh, North Carolina 27617
    United States

    Site Not Available

  • IR Centers

    Raleigh 4487042, North Carolina 4482348 27617
    United States

    Site Not Available

  • Orthopedic and Fracture Specialists (O&FS)

    Beaverton, Oregon 97007
    United States

    Site Not Available

  • Orthopedic and Fracture Specialists (O&FS)

    Portland, Oregon 97225
    United States

    Site Not Available

  • Orthopedic and Fracture Specialists (O&FS)

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • IR Centers

    Leesburg, Virginia 20176
    United States

    Site Not Available

  • IR Centers

    Leesburg 4769125, Virginia 6254928 20176
    United States

    Site Not Available

  • Nano Medical Clinic

    Tashkent, Uzbekistan 100095
    Uzbekistan

    Site Not Available

  • Nano Medical Clinic

    Tashkent 1512569, Uzbekistan 100095
    Uzbekistan

    Site Not Available

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