SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization

NCT06550024 | Active Not Recruiting FDA Device

• 1 other identifier: CI570
• Study Type: interventional
• Target: 89
• Locations: 4 countries
• Sites: 8

Brief Summary

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

Conditions

Osteo Arthritis Knee; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis

Keywords

Genicular Artery Embolization; GAE; Knee Embolization; Knee OA; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Proportion of Responders at 1 Month and 3 Month

  1 Month and 3 Months

• Change in mean WOMAC Pain

  1 Month, 3 Months and 6 Months

• Change in Numeric Rating Scale (NRS)

  1 Month, 3 Months and 6 Months

Study Arms (2)

Genicular Artery Embolization (GAE)

EXPERIMENTAL

Temporary Embolization of Genicular Arteries using Resorbable Microspheres

Device: SakuraBead Resorbable Microspheres

Corticosteroid Injection

ACTIVE COMPARATOR

Corticosteroid injection in the knee

Drug: Corticosteroid Injection

Interventions

SakuraBead Resorbable Microspheres DEVICE

Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres

Genicular Artery Embolization (GAE)

Corticosteroid Injection DRUG

Corticosteroid injection in the knee

Corticosteroid Injection

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• CrannMed: lead

Study Sites (8)

University of Alabama Medicine

Birmingham, Alabama, 35233, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Advanced Vascular Institute

Panama City, Florida, 32405, United States

Location

IR Centers

Raleigh, North Carolina, 27617, United States

Location

IR Centers

Leesburg, Virginia, 20176, United States

Location

Bokhua Memorial Cardiovascular Center

Tbilisi, Georgia

Location

Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

Location

Nano Medical Clinic

Tashkent, Uzbekistan, 100095, Uzbekistan

Location

MeSH Terms

Conditions

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: November 28, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); GB (1); UZ (1); GE (1)