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Artery Pseudoaneurysm After PCNLNCT07724912

Renal Artery Pseudoaneurysm After PCNL

An observational study of Artery Pseudoaneurysm After PCNL, run by Botkin Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In a multicenter retrospective study, to assess the incidence and risk factors of renal artery pseudoaneurysm after percutaneous nephrolithotomy, and to characterize the clinical presentation and treatment outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Artery Pseudoaneurysm After PCNL
What is being tested?
Embolization of a renal artery branch pseudoaneurysm
Type of treatment
Surgery or procedure
How many people
50 participants
Where
No sites listed yet
Study dates
9 Sep 2026to 29 May 2027
How long will I take part?
1 Year
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
  • Adult, Older adult

Study population: Patients with renal artery pseudoaneurysm after PCNL

Who may be able to join

  • Age ≥18 years
  • Underwent percutaneous nephrolithotomy (PCNL)
  • Renal artery pseudoaneurysm confirmed by CT angiography
  • Follow-up ≥30 days post-procedure

Who cannot join

  • Known pre-existing renal vascular anomalies or abnormalities
  • Incomplete medical records (missing key data for analysis)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Risk Factors, Clinical Features and Outcomes of Management for Renal Artery Pseudoaneurysm After PCNL: A Multicenter Retrospective Study

In a multicenter retrospective study, to assess the incidence and risk factors of renal artery pseudoaneurysm after percutaneous nephrolithotomy, and to characterize the clinical presentation and treatment outcomes.

Read the detailed description

Pseudoaneurysm (PA) is a false lumen that arises from a defect in the layers of the arterial wall, around which a hematoma forms, and reactive fibrosis leads to the development of a saccular structure connected to the arterial lumen by a neck; renal arteriovenous fistula results from injury to the wall of the main or segmental renal arteries, and the injury may be traumatic (most commonly penetrating), iatrogenic, or sometimes secondary to an inflammatory or neoplastic process. The main iatrogenic causes include percutaneous nephrolithotomy (PCNL), percutaneous renal biopsy, percutaneous nephrostomy, and renal resection; diagnosis is primarily based on color Doppler ultrasound, contrast-enhanced computed tomographic angiography (CTA), or angiography, and treatment options depend on the site of injury, with endovascular embolization being the first-line therapy. The aim of this study is to identify, within a multicenter retrospective study, the incidence and risk factors for the development of renal artery pseudoaneurysm in patients following percutaneous nephrolithotomy, and to determine the clinical features and effectiveness of treatment methods. The objectives of the study are: to assess the incidence of this complication; to evaluate the clinical presentation and severity of the complication; to determine the nature and effectiveness of treatment methods; to assess treatment outcomes; to identify risk factors for the development of the complication; and to develop a risk assessment scale for pseudoaneurysm after PCNL based on the identified risk factors. The study type and design is a retrospective multicenter cohort study. Inclusion criteria are: age ≥18 years, patients who underwent PCNL, pseudoaneurysm confirmed by CTA or angiography, and a follow-up period of at least 30 days after the procedure. Exclusion criteria are: known pre-existing vascular anomalies or abnormalities in the kidney, and absence of key data required for analysis (incomplete medical records). Outcomes assessed include: development of renal artery branch pseudoaneurysm after PCNL; time to detection of PA after PCNL; development of bleeding from the pseudoaneurysm; effectiveness of conservative methods; effectiveness of endovascular intervention; and effectiveness of renal exploration and nephrectomy. Materials and methods: the study will analyze medical record data from patients who underwent PCNL and developed the complication of renal artery pseudoaneurysm; data will be provided by different centers that perform such procedures. Sample size calculation was performed accounting for clustering of data across centers: with an expected embolization rate of 80%, precision of ±10%, confidence level of 95%, intraclass correlation coefficient of 0.03, and an average cluster size of 8 patients, the design effect was 1.21, and the adjusted sample size is 75 patients with pseudoaneurysm.

Being tested
Embolization of a renal artery branch pseudoaneurysm
Keywords
Renal artery pseudoaneurysm, percutaneous nephrolithotomy, PCNL, retrospective multicenter study, risk factors, incidence, endovascular embolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Embolization of a renal artery branch pseudoaneurysmProcedure or surgery

    Endovascular embolization of a renal artery branch pseudoaneurysm is performed under local anesthesia and sedation. Following Seldinger puncture of the common femoral artery, an introducer sheath is placed. Diagnostic renal angiography is performed to localize the pseudoaneurysm and assess the vascular anatomy. Selective catheterization of the affected branch is achieved using a microcatheter. An embolic material is delivered into the pseudoaneurysm lumen or into the feeding vessel. Depending on the anatomical features and operator preference, microcoils (Guglielmi detachable coils or fibered coils), liquid embolic agents (Onyx, glutaraldehyde-acrylic copolymer), or a combination thereof are used. Completion angiography is performed to confirm complete occlusion of the pseudoaneurysm and preservation of blood flow in the unaffected renal artery branches. After removal of the introducer sheath, compression of the puncture site is applied for hemostasis.

Study groups in NCT07724912
Study groupRoleWhat they receive
Patients with renal artery pseudoaneurysm after PCNLPatients who underwent percutaneous nephrolithotomy and subsequent development of renal artery pseudoaneurysm, verified by CT angiography, where the complication could either present with bleeding or have an asymptomatic course
Receives: Procedure: Embolization of a renal artery branch pseudoaneurysm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically)

    Measured: 1 month

  2. the proportion of patients with pseudoaneurysm who have the risk factors identified by the study.

    Measured: 1 month

Secondary outcomes (2)
  1. Frequency of hemodynamic instability requiring the use of inotropic agents (unit of measurement: yes/no; measurement instrument: monitoring of blood pressure and heart rate, protocol of inotropic administration).

    Measured: 1 year

  2. Volume of blood loss requiring transfusi

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study start9 Sep 2026 (estimated)
  3. Primary completion7 May 2027 (estimated)
  4. Study completion29 May 2027 (estimated)

Resources

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-control
Time perspective
Other
Enrolment
50 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07724912
Sponsor's protocol ID
Urology20261
Status last verified
May 2026
First submitted
6 May 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Artery Pseudoaneurysm After PCNL, run by Botkin Hospital.

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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Nikita Astakhov (+7 (968) 490-46-72, botkinhospital@zdrav.mos.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 24 Jul 2026.

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