Geniculate Artery Embolization for Treatment of Osteoarthritis

NCT ID: NCT04379700

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2025-03-12

Brief Summary

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.

Detailed Description

The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embolization Group

23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.

Group Type: EXPERIMENTAL

Transcatheter arterial embolization

Intervention Type: PROCEDURE

Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.

Embozene™ Microspheres

Intervention Type: DEVICE

Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes.

Interventions

Transcatheter arterial embolization

Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.

Intervention Type: PROCEDURE

Embozene™ Microspheres

Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 30-80 years of age of any gender;

2. Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;

3. Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);

5. Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.

Exclusion Criteria

1. Active systemic or local knee infection;

2. Active malignancy;

3. Life expectancy less than 12 months;

4. Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;

5. Ipsilateral knee intra-articular injection in the last 3 months;

6. Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;

7. Pregnant during the study period;

8. Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;

9. Body weight greater than 200 Kg;

10. Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;

11. Known history of contrast allergy resulting in anaphylaxis;

12. Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain);

13. Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);

14. Known avascular necrosis in the target knee;

15. Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bedros Taslakian, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-00370

Identifier Type: -

Identifier Source: org_study_id