SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization (SURE)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteoarthritis; Osteo Arthritis Knee
• Intervention / Treatment: Device: SakuraBead Resorbable Microspheres; Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Bokhua Memorial Cardiovascular Center
• United Kingdom
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Medicine
  • California
    • Torrance, California, United States, 90502
      • Harbor UCLA Medical Center
  • Florida
    • Panama City, Florida, United States, 32405
      • Advanced Vascular Institute
  • North Carolina
    • Raleigh, North Carolina, United States, 27617
      • IR Centers
  • Virginia
    • Leesburg, Virginia, United States, 20176
      • IR Centers
• Uzbekistan
  • Uzbekistan
    • Tashkent, Uzbekistan, Uzbekistan, 100095
      • Nano Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genicular Artery Embolization (GAE); Temporary Embolization of Genicular Arteries using Resorbable Microspheres	Device: SakuraBead Resorbable Microspheres; Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Active Comparator: Corticosteroid Injection; Corticosteroid injection in the knee	Drug: Corticosteroid Injection; Corticosteroid injection in the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint - Proportion of Responders	Compare the proportion of responders* (defined as ≥50% reduction in WOMAC Pain** score and ≥2 point reduction in NRS***) between the Investigational procedure and Control at 6 months.; Non-responders will include subjects experiencing device-related SAEs. **Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome ***NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain).	6 Months
Primary Safety Endpoint - Freedom from treatment-related SAEs	Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control).	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Responders at 1 Month and 3 Month	Compare the proportion of responders* (defined as ≥50% reduction in WOMAC Pain** score and ≥2 point reduction in NRS***) between the Investigational procedure and Control at 1 Month and 3 Months.; Non-responders will include subjects experiencing device-related SAEs. **Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome ***NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain).	1 Month and 3 Months
Change in mean WOMAC Pain	Compare mean change from baseline in the Western Ontario and McMaster University Osteoarthritis Index Pain (WOMAC Pain, Scale: 0-20, where a lower score represents a better outcome) between the Investigational procedure and Control at 1 Month, 3 Months and 6 Months.	1 Month, 3 Months and 6 Months
Change in Numeric Rating Scale (NRS)	Compare mean decrease in pain (measured using the Numeric Rating Scale (NRS)) between the Investigational procedure and Control at 1 month, 3 months and 6 months. Scale: 0-10, where a lower score means a better outcome.	1 Month, 3 Months and 6 Months

Collaborators and Investigators

• Sponsor: CrannMed

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Knee OA; Genicular Artery Embolization; GAE; Knee Embolization
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Diseases; Rheumatic Diseases; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: CI570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No