ClinicalTrials.gg
Not yet recruitingNCT07724912Updated Jul 24, 2026

Renal Artery Pseudoaneurysm After PCNL

An observational study in Artery Pseudoaneurysm After PCNL, sponsored by Botkin Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Botkin Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Artery Pseudoaneurysm After PCNL

Keywords

  • Renal artery pseudoaneurysm, percutaneous nephrolithotomy, PCNL, retrospective multicenter study, risk factors, incidence, endovascular embolization
03

In context

Lead sponsor

Botkin Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with renal artery pseudoaneurysm after PCNL

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥18 years

Underwent percutaneous nephrolithotomy (PCNL)

Renal artery pseudoaneurysm confirmed by CT angiography

Follow-up ≥30 days post-procedure

Exclusion criteria

Exclusion Criteria:

Known pre-existing renal vascular anomalies or abnormalities

Incomplete medical records (missing key data for analysis)

05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
50 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Patients with renal artery pseudoaneurysm after PCNL

    Patients 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

    Procedure: Embolization of a renal artery branch pseudoaneurysm

Interventions

  • ProcedureEmbolization of a renal artery branch pseudoaneurysm

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: 1 month

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

    Time frame: 1 month

Secondary outcomes

  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).

    Time frame: 1 year

  2. Volume of blood loss requiring transfusi

    Time frame: 1year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for May 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2026
First posted
Jul 24, 2026
StartEst.
Sep 9, 2026
Primary completionEst.
May 7, 2027
CompletionEst.
May 29, 2027
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07724912
Lead sponsor
Botkin Hospital
Responsible party
Malkhasyan Vigen Andreevich (Head of the department, Botkin Hospital) — Principal investigator
First posted
Jul 24, 2026
Start date
Sep 9, 2026 (estimated)
Primary completion
May 7, 2027 (estimated)
Completion
May 29, 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

Nikita Astakhov
Contact
botkinhospital@zdrav.mos.ru
+7 (968) 490-46-72
Vigen Malkhasyan, Doctor of Medical Sciences
study chair · Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Department of Healthcare; 2 Russian University of Medicine of the Ministry of Health of Russia
Dmitry Pushkar, Academician of the RAS
study director · Botkin Moscow Multidisciplinary Scientific and Clinical Center of the Moscow Department of Healthcare; 2 Russian University of Medicine of the Ministry of Health of Russia

Oversight

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

Not currently enrolling

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

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