Achilles Tendinopathy Embolization

Phase 1Not Yet RecruitingNCT07477860

Joint & Vascular Institute10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Achilles Tendinopathy (AT)

Interventions

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain Change

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

Time frame: Baseline to 12 months

Safety (rate of adverse events)

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

Time frame: Baseline to 12 month follow-up