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Superselective Renal Artery Embolization for Renal Angiomyolipoma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07538908
Acronym
EAL
Enrollment
50
Registered
2026-04-20
Start date
2026-04-06
Completion date
2027-05-10
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selective Endovascular Embolization of Kidney Artery

Keywords

angiomyolipoma; embolization; endovascular treatment; minimally invasive technologies

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.

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

Sponsors

Botkin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stopping the blood supply to the angiomyolipoma1-3 daysAfter 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.

Secondary

MeasureTime frameDescription
Reduction in the size of the angiomyolipoma.1 yearOne year later, on a follow-up computed tomography scan, a decrease in the size of the angiomyolipoma should be noted.

Countries

Russia

Contacts

STUDY_DIRECTORVigen Malkhasyan, Doctor of Medical Sciences

Head of the department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026