Selective Endovascular Embolization of Kidney ArteryEALNCT07538908
Superselective Renal Artery Embolization for Renal Angiomyolipoma
An observational study of Selective Endovascular Embolization of Kidney Artery, run by Botkin Hospital at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Selective Endovascular Embolization of Kidney Artery
- What is being tested?
- Selective endovascular embolization of kidney artery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 6 Apr 2026to 10 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patiants with Angiomyolipoma and Inclusion Criteria
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Selective endovascular embolization of kidney artery
- Keywords
- angiomyolipoma; embolization; endovascular treatment; minimally invasive technologies
- Medical subject headings
- Angiomyolipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective endovascular embolization of kidney arteryProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with angiomyolipoma | Patients with angiomyolipoma meeting the inclusion criteria for the study Receives: Procedure: Selective endovascular embolization of kidney artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start6 Apr 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selective Endovascular Embolization of Kidney ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botkin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drozdov Pavel, Botkin Hospital
- Investigators
- Vigen Malkhasyan, Doctor of Medical Sciences, Study director, Head of the department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538908
- Sponsor's protocol ID
- EAL09042026
- Acronym
- EAL
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Superselective Embolization of the Branches of the Renal Artery in the Treatment of Renal Angiomyolipoma: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07538908
- Acronym / sponsor ID
- EAL / EAL09042026
- Keywords
- angiomyolipoma; embolization; endovascular treatment; minimally invasive technologies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Botkin HospitalUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with angiomyolipoma | – | Procedure: Selective endovascular embolization of kidney arteryPatients with angiomyolipoma meeting the inclusion criteria for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiants with Angiomyolipoma and Inclusion Criteria
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective endovascular embolization of kidney arteryThrough 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 | Procedure or surgery | Patients with angiomyolipoma |
Primary outcome
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 secondary outcome
Reduction in the size of the angiomyolipoma.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vigen Malkhasyan, Doctor of Medical Sciences study director
Head of the department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Selective Endovascular Embolization of Kidney Artery, run by Botkin Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stopping the blood supply to the angiomyolipoma (time frame: 1-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.