Achilles Tendinopathy Embolization

Purpose

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: 1. Does this procedure successfully reduce chronic Achilles tendon pain as measured by the Visual Analog Scale (VAS) over 12 months? 2. How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device? Participants will: - 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.

Condition

  • Achilles Tendinopathy (AT)

Eligibility

Eligible Ages
Between 25 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental: Achilles Tendonopathy Embolization
  • Device: LipioJoint
    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.

Recruiting Locations

Joint and Vascular Institute
Libertyville, Illinois 60048
Contact:
Layth Alkhani
847-584-3959
lalkhani@jointvascular.com

More Details

Status
Recruiting
Sponsor
Joint & Vascular Institute

Study Contact

Layth Alkhani
847-584-3959
lalkhani@jointvascular.com