Minimally invasive artery embolization for chronic Achilles tendon pain
Achilles Tendinopathy Embolization (ATE) With LipioJoint: An Early Feasibility Study
This trial will try injecting a temporary Lipiodol emulsion into blood vessels feeding the Achilles tendon to reduce chronic tendon pain in adults 25 to 80 who haven't improved after conservative treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Joint & Vascular Institute Industry-sponsored |
| Locations | 1 site (Libertyville, Illinois) |
| Trial ID | NCT07477860 on ClinicalTrials.gov |
What this trial studies
Participants undergo a minimally invasive catheter procedure in which a radiologist injects a temporary blocking agent (LipioJoint/Lipiodol emulsion) into specific arteries supplying the affected Achilles tendon. Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline and at 1, 3, 6, and 12 months after the procedure, with a phone check one day after treatment to screen for early side effects. The study is a Phase 1 interventional trial focused on feasibility and safety, tracking serious adverse events related to the device and procedure over 12 months. The goal is to determine whether the procedure can safely and durably reduce chronic Achilles pain in adults who are non-surgical candidates or wish to avoid surgery.
Who should consider this trial
Good fit: Adults aged 25–80 with chronic Achilles tendinopathy resistant to at least three months of conservative care, reporting at least 4/10 pain on the VAS and who prefer to avoid surgery are the intended participants.
Not a fit: People with acute fracture/trauma, inflammatory tendon disease, recent steroid injection (within 90 days), peripheral arterial disease, severe contrast allergy, impaired kidney function (GFR <45 or creatinine >2.0 mg/dL), type 1 diabetes, pregnancy/breastfeeding, anticoagulation or irreversible coagulopathy, or tendon rupture are excluded and unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this procedure could reduce chronic Achilles tendon pain and offer a less invasive alternative to surgery.
How similar studies have performed: Early case series and small observational studies of arterial embolization for tendinopathies have reported promising pain reductions, but larger controlled trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Libertyville, Illinois
- Joint and Vascular Institute — Libertyville, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Layth Alkhani
- Email: lalkhani@jointvascular.com
- Phone: 847-584-3959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.