Superselective Renal Artery Embolization for Renal Angiomyolipoma

NCT07538908 | Active Not Recruiting

• 1 other identifier: EAL09042026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Selective Endovascular Embolization of Kidney Artery

Keywords

angiomyolipoma; embolization; endovascular treatment; minimally invasive technologies

Outcome Measures

Primary Outcomes (1)

• Stopping the blood supply to the angiomyolipoma

  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 Outcomes (1)

• Reduction in the size of the angiomyolipoma.

  1 year

Study Arms (1)

Patients with angiomyolipoma

Patients with angiomyolipoma meeting the inclusion criteria for the study

Procedure: Selective endovascular embolization of kidney artery

Interventions

Selective endovascular embolization of kidney artery PROCEDURE

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

Patients with angiomyolipoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patiants with Angiomyolipoma and Inclusion Criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Botkin Hospital: lead

Study Sites (1)

Botkin City Hospital

Moscow, Russia

Location

MeSH Terms

Conditions

Angiomyolipoma

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Perivascular Epithelioid Cell Neoplasms

Study Officials

• Vigen Malkhasyan, Doctor of Medical Sciences

  Head of the department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

RU (1)