Status:
RECRUITING
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Lead Sponsor:
CrannMed
Conditions:
Osteo Arthritis Knee
Joint Diseases
Eligibility:
All Genders
40-79 years
Phase:
NA
Brief Summary
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Detailed 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 patien...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT06550024
Start Date
November 28 2024
End Date
April 1 2027
Last Update
October 30 2025
Active Locations (9)
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1
University of Alabama Medicine
Birmingham, Alabama, United States, 35233
2
Harbor UCLA Medical Center
Torrance, California, United States, 90502
3
Advanced Vascular Institute
Panama City, Florida, United States, 32405
4
IR Centers
Raleigh, North Carolina, United States, 27617