Superselective Renal Artery Embolization for Renal Angiomyolipoma (EAL)

April 13, 2026 updated by: Drozdov Pavel, Botkin Hospital

Endovascular Superselective Embolization of the Branches of the Renal Artery in the Treatment of Renal Angiomyolipoma: a Prospective Cohort Study

To evaluate the efficacy and safety of selective endovascular embolization in the treatment of renal angiomyolipoma (AML). Materials and Methods: A prospective analysis will be conducted on patients who undergo transcatheter renal artery embolization for renal angiomyolipoma. Inclusion criteria will be radiologically confirmed angiomyolipoma based on CT and/or MRI findings and the presence of clinical indications for embolization. The primary outcomes will include the assessment of changes in serum creatinine and hemoglobin levels post-procedure, technical success rates, and the incidence of any complications. Expected Results: Data on patient demographics, tumor characteristics, and procedural outcomes will be collected and analyzed. Conclusion: This study aims to determine whether selective endovascular embolization is a safe and effective treatment modality for renal angiomyolipoma, with the expectation of demonstrating a high rate of technical success while preserving renal function.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia
        • Botkin City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patiants with Angiomyolipoma and Inclusion Criteria

Description

Inclusion Criteria:

Renal angiomyolipoma confirmed by computed tomography or magnetic resonance imaging; Indications for surgical treatment (episodes of acute or recurrent bleeding, large tumor size, high risk of abdominal trauma due to specific lifestyle and working conditions, planned pregnancy in women, and limited access to emergency medical care); The patient's informed consent to undergo minimally invasive intervention, formed after being explained the nature of the disease, potential risks, alternative treatment methods, and expected outcomes.

Exclusion Criteria:

Angiomyolipoma of a solitary kidney; Severe renal failure (CKD stage 3a or higher); Pregnancy or lactation; Allergy to contrast agents or other drugs used during embolization; Coagulopathies or hemostatic disorders not amenable to correction;• Active urinary tract infection; Suspicion of malignant transformation (angiomyoliposarcoma) based on CT/MRI data or the presence of a malignant kidney tumor concurrently with AML; Non-operability or impossibility of catheterizing the feeding vessels (based on angiography); Patient's mental status preventing adequate decision-making and reducing the level of self-care;• Patient's unwillingness to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with angiomyolipoma
Patients with angiomyolipoma meeting the inclusion criteria for the study
Procedure: Selective endovascular embolization of kidney artery
Through arterial access (femoral, radial, or brachial), a catheter is advanced to the artery supplying the angiomyolipoma. Embolic agents used included Contour and Embosphere microspheres sized 50-710 μm. Blocking the blood vessels of the kidney that supply the tumor causes ischemia of the tumor, leading to stabilization of its growth and regression.Other Name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stopping the blood supply to the angiomyolipoma
Time Frame: 1-3 days
After performing selective embolization of the renal vessel, the blood supply to the renal angiomyolipoma should be completely stopped. At the same time, post-embolization complications should be minimized, and kidney function should not be impaired. The result must be confirmed by instrumental imaging.
1-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in the size of the angiomyolipoma.
Time Frame: 1 year
One year later, on a follow-up computed tomography scan, a decrease in the size of the angiomyolipoma should be noted.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Botkin Hospital

Investigators

  • Study Director: Vigen Malkhasyan, Doctor of Medical Sciences, Head of the department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2026

Primary Completion (Estimated)

April 10, 2027

Study Completion (Estimated)

May 10, 2027

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAL09042026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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