Achilles Tendinopathy Embolization

NCT07477860 | Recruiting Phase 1 FDA Device

• 1 other identifier: G260029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn determine the feasibility of arterial embolization using Lipiodol emulsion to safely and effectively treat chronic Achilles tendon pain due to Achilles tendinopathy in adults aged 25 to 80. The main questions it aims to answer are:

• Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels supplying the Achilles tendon.
• Receive a phone call one day after the procedure to check for early side effects.
• Participate in four follow-up visits over the course of one year (at 1, 3, 6, and 12 months). Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.

Conditions

Achilles Tendinopathy (AT)

Keywords

achilles

Outcome Measures

Primary Outcomes (2)

• Pain Change

  Pain - measured via visual analogue scale at baseline, 1-month, 3-month, 6-month, and 12-month follow-up

  Baseline to 12 months

• Safety (rate of adverse events)

  Safety - Percentage of subjects without serious adverse events related to the medical device

  Baseline to 12 month follow-up

Study Arms (1)

Experimental: Achilles Tendonopathy Embolization

EXPERIMENTAL

Device: LipioJoint

Interventions

LipioJoint DEVICE

Participants will receive a transcatheter arterial embolization of the arterial branches supplying the Achilles tendon. The intervention involves selective catheterization of the peritendinous branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic Achilles tendinopathy to alleviate pain and reduce inflammation.

Experimental: Achilles Tendonopathy Embolization

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 25 years
• Subject provides written informed consent
• Patient with Achilles tendinopathy refractory to 3 months of conservative management
• Self reported pain of at least 4/10 on visual analog scale (VAS)
• Non-surgical candidate/looking to avoid surgery

You may not qualify if:

• Achilles tendon pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, tendon rupture, and etiologies related to bone mineral density
• Steroid injection in the last 90 days from the embolization procedure
• Known severe allergy to Lipiodol and/or iodinated contrast media
• Diagnosis of peripheral arterial disease affecting the lower extremities
• Pregnancy or breastfeeding
• Anticoagulation or irreversible coagulopathy
• GFR \<45 or Serum creatinine \> 2.0 mg/dl
• Type 1 Diabetes Mellitus

Sponsors & Collaborators

• Joint & Vascular Institute: lead

Study Sites (1)

Joint and Vascular Institute

Libertyville, Illinois, 60048, United States

RECRUITING

Central Study Contacts

Layth Alkhani

CONTACT

847-584-3959; lalkhani@jointvascular.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)