Genicular Artery Embolization for the Treatment of Knee Osteoarthritis

NCT ID: NCT03491397

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2021-10-29

Brief Summary

The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

Detailed Description

This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.

Conditions

Knee Osteoarthritis; Degenerative Joint Disease of Knee

Study Design

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

Study Groups

GAE OA

Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.

Group Type: EXPERIMENTAL

Embozene MicroSpheres

Intervention Type: DEVICE

Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

Interventions

Embozene MicroSpheres

Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

Intervention Type: DEVICE

Other Intervention Names

Color-Advanced Microspheres; Microspheres for Embolization

Eligibility Criteria

Inclusion Criteria

• Provided informed consent
• Age ≥ 40 years and ≤ 80 years
• Life expectancy greater than 12 months
• Ineligibility for or refusal of surgical management
• Moderate-severe knee pain as determined by visual analog scale > 4
• Osteoarthritis based on xray
• Local knee tenderness
• Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)

Exclusion Criteria

• Chronic renal insufficiency (serum creatinine >2 mg/dL)
• Uncorrectable bleeding diathesis: international normalized ratio (INR) >1.6, Platelets <50,000
• Significant arterial atherosclerosis that would limit selective angiography
• Allergy to iodinated contrast agents that is not responsive to steroid management
• Active Infection or malignancy
• Appropriate candidate for knee replacement surgery determined by clinical and physical examination
• Recent (within 3 months) or active cigarette use

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Siddharth Padia, MD

OTHER

Sponsor Role: lead

Responsible Party

Siddharth Padia, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Siddharth Padia, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Siddharth Padia, M.D.

Santa Monica, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-000560

Identifier Type: -

Identifier Source: org_study_id