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Active, not recruitingNCT07538908EALUpdated Apr 20, 2026

Superselective Renal Artery Embolization for Renal Angiomyolipoma

An observational study in Selective Endovascular Embolization of Kidney Artery, sponsored by Botkin Hospital. Active, not recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Botkin Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Selective Endovascular Embolization of Kidney Artery

Keywords

  • angiomyolipoma; embolization; endovascular treatment; minimally invasive technologies
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patiants with Angiomyolipoma and Inclusion Criteria

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

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.

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with angiomyolipoma

    Patients with angiomyolipoma meeting the inclusion criteria for the study

    Procedure: Selective endovascular embolization of kidney artery

Interventions

  • ProcedureSelective 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

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What researchers measure

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.

    Time frame: 1-3 days

Secondary outcomes

  1. Reduction in the size of the angiomyolipoma.

    One year later, on a follow-up computed tomography scan, a decrease in the size of the angiomyolipoma should be noted.

    Time frame: 1 year

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Study locations

1 site
  • Botkin City Hospital
    Moscow, Russia
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Registry details

Key details

Study ID
NCT07538908
Lead sponsor
Botkin Hospital
Responsible party
Drozdov Pavel (Senior Researcher, Botkin Hospital) — Principal investigator
First posted
Apr 20, 2026
Start date
Apr 6, 2026
Primary completion
Apr 10, 2027 (estimated)
Completion
May 10, 2027 (estimated)
Last update
Apr 20, 2026

Study contacts

Vigen Malkhasyan, Doctor of Medical Sciences
study director · Head of the department

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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