Clinical trial NCT06550024: SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Official title: SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arthritis
Osteoarthritis
Keywords: Genicular Artery Embolization
GAE
Knee Embolization
Knee OA
Knee Osteoarthritis
Lead sponsor: CrannMed
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 89
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 patients who will be followed up for a period of 2 years.

Eligibility criteria: 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-inflammatory drugs, 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 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 pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history 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, or planning pregnancy in the following 12 months, or
12. 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
13. Contraindication to MRI, or
14. At the discretion of the Principal Investigator

Primary outcomes:
measure: Primary Efficacy Endpoint - Proportion of Responders
timeFrame: 6 Months
measure: Primary Safety Endpoint - Freedom from treatment-related SAEs
timeFrame: 6 Months
Secondary outcomes:
measure: Proportion of Responders at 1 Month and 3 Month
timeFrame: 1 Month and 3 Months
measure: Change in mean WOMAC Pain
timeFrame: 1 Month, 3 Months and 6 Months
measure: Change in Numeric Rating Scale (NRS)
timeFrame: 1 Month, 3 Months and 6 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medicine
state: Alabama
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Raleigh
country: United States
facility: IR Centers
state: North Carolina
city: Portland
country: United States
facility: Orthopedic and Fracture Specialists (O&FS)
state: Oregon
city: Leesburg
country: United States
facility: IR Centers
state: Virginia
city: Tbilisi
country: Georgia
facility: Bokhua Memorial Cardiovascular Center
city: Tashkent
country: Uzbekistan
facility: Nano Medical Clinic
Study officials:
References: