Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

NCT04472091 | Withdrawn FDA Device

• 2 other identifiers: 57046IDE G200111
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Pain Swelling; Knee Arthritis; Arterial Occlusion

Keywords

Knee osteoarthritis; Genicular artery embolization; Geniculate artery embolization

Outcome Measures

Primary Outcomes (4)

• Number of patients with treatment related adverse events

  Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  1 month post GAE

• Number of patients with treatment related adverse events

  Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  6 months post GAE

• Number of patients with treatment related adverse events

  Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  12 months post GAE

• Number of patients with treatment related adverse events

  Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  24 months post GAE

Secondary Outcomes (8)

• Mean change from baseline pain scores

  Baseline to 1 month post GAE

• Mean change from baseline pain scores

  Baseline to 6 months post GAE

• Mean change from baseline pain scores

  Baseline to 12 months post GAE

• Mean change from baseline pain scores

  Baseline 24 months post GAE

• Mean change from baseline knee function scores

  Baseline to 1 month post GAE

Study Arms (1)

Genicular artery embolization

EXPERIMENTAL

Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.

Device: Genicular artery embolization (GAE)

Interventions

Genicular artery embolization (GAE) DEVICE

Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).

Genicular artery embolization

Eligibility Criteria

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

You may qualify if:

• Provide informed consent
• Age ≥ 40 years
• Moderate to severe knee pain (VAS \>40 mm)
• Pain refractory to 3 months of conservative treatments, including at least one of the following:
• a. Anti-inflammatory medications
• b. Physical therapy
• c. Intra-articular injections
• Kellgren-Lawrence radiographic grade 1, 2, or 3 disease
• MRI features of active synovitis (synovial thickening and/or enhancement on MRI).
• Ineligibility or refusal of surgical management.
• Local knee tenderness

You may not qualify if:

• Rheumatoid or infectious arthritis
• Advanced lower extremity atherosclerosis that would limit selective angiography
• Local knee infection
• Prior knee surgery (excluding arthroscopic/meniscal interventions)
• Uncorrectable coagulopathy (INR\>1.8, platelets\<50,000/µL)
• Iodine allergy resulting in anaphylaxis
• Chronic renal insufficiency (serum creatinine \>2 mg/dL)
• Life expectancy less than 6 months

Sponsors & Collaborators

• Andrew Picel: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrew C Picel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: January 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)