Artery Pseudoaneurysm After PCNLNCT07724912
Renal Artery Pseudoaneurysm After PCNL
An observational study of Artery Pseudoaneurysm After PCNL, run by Botkin Hospital.
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.
- Conditions
- Artery Pseudoaneurysm After PCNL
- 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 group | Role | What they receive |
|---|---|---|
| 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 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.
The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically)
Measured: 1 month
the proportion of patients with pseudoaneurysm who have the risk factors identified by the study.
Measured: 1 month
Secondary outcomes (2)
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
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.
- First posted24 Jul 2026
- Study start9 Sep 2026 (estimated)
- Primary completion7 May 2027 (estimated)
- Study completion29 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery Pseudoaneurysm After PCNLStudies 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-control
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Botkin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malkhasyan Vigen Andreevich, Botkin Hospital
- Investigators
- 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 RussiaDmitry 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
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Clinical Features and Outcomes of Management for Renal Artery Pseudoaneurysm After PCNL: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07724912
- Acronym / sponsor ID
- Urology20261
- Conditions
- Artery Pseudoaneurysm After PCNL
- Keywords
- Renal artery pseudoaneurysm, percutaneous nephrolithotomy, PCNL, retrospective multicenter study, risk factors, incidence, endovascular embolization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Botkin HospitalUniversity, hospital or other
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 7 May 2027 (estimated)
- Study completion
- 29 May 2027 (estimated)
- First posted
- 24 Jul 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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with renal artery pseudoaneurysm after PCNL | – | Procedure: Embolization of a renal artery branch pseudoaneurysmPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with renal artery pseudoaneurysm after PCNL
Key inclusion criteria (4 listed)
- Age ≥18 years
- Underwent percutaneous nephrolithotomy (PCNL)
- Renal artery pseudoaneurysm confirmed by CT angiography
- Follow-up ≥30 days post-procedure
Key exclusion criteria (2 listed)
- Known pre-existing renal vascular anomalies or abnormalities
- Incomplete medical records (missing key data for analysis)
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 |
|---|---|---|
| Embolization of a renal artery branch pseudoaneurysmEndovascular 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. | Procedure or surgery | Patients with renal artery pseudoaneurysm after PCNL |
Primary outcome
The number of recorded pseudoaneurysms of the renal artery branches after percutaneous nephrolithotomy (confirmed angiographically)
Time frame: 1 month
the proportion of patients with pseudoaneurysm who have the risk factors identified by the study.
Time frame: 1 month
2 secondary outcomes
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
Volume of blood loss requiring transfusi
Time frame: 1year
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 24 Jul 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.
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
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.