AAA - Abdominal Aortic AneurysmAAAhypotensionNCT07511101
Perioperative Hypotension and Survival After Elective AAA Repair
An observational study of AAA - Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Background: An abdominal aortic aneurysm (AAA) is a localized dilatation of the infrarenal aorta that, when it meets critical criteria, can rupture and cause a vital emergency, requiring immediate surgery with a mortality rate close to 85%(1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- How many people
- 511 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jan 2023to 1 Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with an abdominal aortic aneurysm treated electively between 2013 and 2022.
Who may be able to join
- Age > 18 years
- Elective AAA repair between 2013 and 2022 (endovascular and open)
Who cannot join
- Data from the blood pressure monitoring system were only available from 2013, so patients treated before January 1th 2013 were excluded.
- Patients were also excluded from the study if registered objection to use their data for research,
- absence of blood pressure data,
- revision surgery after previous endovascular or open repair,
- ruptured aneurysm,
- mycotic aneurysm, or
- treatment with endovascular aneurysm sealing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Perioperative Hypotension After Abdominal Aortic Aneurysm Repair and Its Impact on Early Survival
Background: An abdominal aortic aneurysm (AAA) is a localized dilatation of the infrarenal aorta that, when it meets critical criteria, can rupture and cause a vital emergency, requiring immediate surgery with a mortality rate close to 85%(1). Also, symptomatic AAA and/or imminent rupture is a surgical emergency that should be recognized and treated promptly. Elective procedures are usually performed in patients with AAA with a diameter greater than 5.5 cm in men and 5.0 cm in women(2,3).
There are different techniques for the surgical repair of AAA, which are divided into two main groups: endovascular and open procedures. The endovascular procedure offers an early survival benefit, better postoperative recovery, and fewer incision-related complications as it is a minimally invasive procedure. However, it requires more re-interventions, but most are mainly minor endovascular procedures. In contrast, an open approach has a better 15-year late survival benefit, associated with greater graft durability, a lower rate of re-interventions, and the additional advantage of being more affordable (4-7).
Read more
Several risk factors have been established around surgical procedures that may affect the outcome, including preoperative and intraoperative hypotension. Preoperative hypotension is one of the most crucial factors, especially when talking about ruptured AAA, where it is present with a high frequency and has been seen as an association with mortality with an AOR of 3.28 (CI 1.75-5.41; P < .001) (8). For intraoperative hypotension, a study showed that it increased the 30-day mortality after an elective open repair of AAA with an OR of 6.61 (CI 0.71-61.07; p = 0.05). Also, it has been associated with liver dysfunction (p < 0.001) and colonic ischemia (P=0.021) (9-11).
However, the frequency and effects of postoperative hypotension in open and endovascular AAA surgery have not been described in the literature despite the everyday use of vasopressor medications (48%) in the immediate medical management following an open AAA repair(12). However, other studies have shown that postoperative hypotension in abdominal surgery is a significant complication that can have adverse effects on the patient. This condition is characterized by a decrease in blood pressure, which can lead to myocardial injury, acute kidney damage, and an increase in short-term mortality(13).
According to literature, postoperative hypotension is common after major abdominal surgeries, and its detection may be suboptimal if routine vital sign assessments are the sole monitoring method. A prospective observational study found that nearly one-quarter of patients experienced episodes of mean arterial pressure (MAP) below 70 mmHg for at least 30 minutes, many of which went undetected through routine evaluations(14). Another study highlighted that prolonged postoperative hypotension, defined by absolute MAP thresholds, is associated with myocardial injury, especially when MAP falls below 65 mmHg for extended periods (15).
In addition, in other vascular interventions like carotid endarterectomy, postoperative hypotension has been associated with increased risks of 30-day mortality, stroke, myocardial infarction, and length of stay(16).
Given the potential implications for adverse perioperative outcomes, it is essential to elucidate potential risk factors to tailor the perioperative management of AAA repair further. Thus, we aim to describe the mortality and determine the risk factors associated with peroperative and postoperative hypotension at 48 hours in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 1-1-2013 until 31-12-2021.
Research question: What were the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 to 2021?
Hypothesis:
Alternate hypothesis: There are specific risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 until 2021.
Read the detailed description
Research design: Observational, monocenter, retrospective cohort study.
Selection Criteria:
- Inclusion criteria: all patients treated open and endovascular for an abdominal aortic aneurysm in Rijnstate between 1-1-2013 and 31-12-2021.
- Exclusion criteria: Patients managed hybrid (EVAR + open) or expectantly.
Objectives:
General Objective: Determine the risk factors associated with per- and postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital from 1-1-2013 until 31-12-2021.
- Specific Objectives:
- Characterize the sociodemographic and clinical variables of the patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
- Determine the risk factors associated with peroperative and postoperative hypotension in patients who underwent an Infrarenal elective open Abdominal Aortic Aneurysm Repair.
- Determine the risk factors associated with peroperative and postoperative hypotension in patients who underwent an Infrarenal elective endovascular Abdominal Aortic Aneurysm Repair.
- Describe the 30-day postoperative mortality associated with each type of management and postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
- Describe the 30-day postoperative secondary clinical outcomes associated with each type of management and postoperative Hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
Analysis unit
The unit of analysis for this study will be mortality as the dependent variable and the presence of peropertive and postoperative hypotension at 48 hours, defined as an SBP less than 90 mmHg, a MAP less than 60 mmHg, or a difference of more than 30 mmHg compared to pre-operative blood pressure (17).
Additionally, the secondary outcomes will include the occurrence of acute kidney injury, acute myocardial infarction, prolonged mechanical ventilation, spinal cord ischemia, stroke, and mesenteric ischemia (13).
Statistical Analysis: The description of the variables will be done by calculating absolute and relative frequencies for qualitative variables and the use of measures of central tendency and dispersion for quantitative variables; parametric and nonparametric statistics will be used depending on the normal distribution of the data, which will be evaluated using Kolmogorov-Smirnov or Shapiro-Wilk.
Bivariate analysis will be performed, the student t-test will be used for normally distributed data, and the Mann-Whitney U and Kruskal-Wallis H tests will be used for non-normally distributed data. Rates and differences in proportions will be estimated using Pearson's c2 test and Fisher's exact test.
Subsequently, a Kaplan-Meier survival analysis will be performed to evaluate mortality up to 30 days after the surgical procedure or until discharge. Sensitivity analyses will be used to calculate survival. Missing values will be excluded from the analysis. A P value of < 0.05 will be considered statistically significant.
A univariate and multivariate logistic regression analysis will study the association between hypotension and risk factors.
Data management:
Each investigator involved in this research project will be responsible for ensuring the protection and security of patient data. Once the final research products have been generated, the principal investigator will be responsible for the final custody of the database and directory of variables.
Bias control: The potential measures of bias for this study and the control strategy for each are:
- Information bias: The possibility that patients do not have all the information necessary to complete the database and incur loss of information should be contemplated. If the clinical history does not contain all the information needed to complete the database, Missing values will be excluded from the analysis.
- Observer bias: This bias can occur when the researcher, knowing the expected outcome, tends to find more cases of this event in a particular cohort. A non-existent association may appear. To avoid this, only the information found in the clinical history or reliable and objective sources of information will be included without interpretation of any variable by the investigators.
- Confounding bias: All results derived from observational studies are potentially influenced by confounding bias. In this type of study confounding bias is understood as a comparability problem whose origin is linked to the impossibility of randomly assigning the exposure of the study subjects. Thus, confounding variables are not equally distributed among the contrast groups, and subjects are exposed for different reasons that depend on cultural and socioeconomic patterns. To reduce the risk of the presence of this bias, different risk factors associated with worse outcomes have been included so that the analysis can control for these factors in case there is a greater presence of these factors in some of the groups that could affect the results.
Expected Results and Impact: Publish one paper with the institutional experience to generate knowledge on this pathology's multidisciplinary management and present an abstract at an international congress.
- Determine the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
- Describe the mortality and secondary clinical outcomes associated with each type of treatment and postoperative hypotension in patients undergoing infrarenal abdominal aortic aneurysm repair.
Ethical aspects: The study is conducted within the ethical principles for medical research on human subjects according to the Declaration of Helsinki - 59th General Assembly, Seoul, Korea, October 2008. CIOMS Guidelines, the Good Clinical Practice Guidelines of the International Conference on Harmonization (GCP/ICH). The present research is classified within the category of no risk. Since it is a retrospective study in which no intervention will be performed.
Access to the research instruments will be limited only to the investigators, who will be ready to give information about the study to organized, approved, and interested entities if they are of an academic and scientific nature, preserving the accuracy of the results. Absolute confidentiality will be maintained, and a good professional, institutional name will be preserved.
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, Intraoperative Hypotension, Postoperative Hypotension, Endovascular Aneurysm Repair, Open Aneurysm Repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-complex AAA repair | Patients treated with standard EVAR | |
| Complex AAA repair | Patients treated by complex endovascular or open AAA repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day survival
30-day survival
Measured: 30 days
Secondary outcomes (3)
1-year survival
1-year survival
Measured: 1-year
Prevalence intra-operative hypotension
Prevalence intra-operative hypotension
Measured: peri-operative
Prevalence post-operative hypotension
Prevalence post-operative hypotension
Measured: until 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start17 Jan 2023
- Primary completion31 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AAA - Abdominal Aortic AneurysmStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 511 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511101
- Sponsor's protocol ID
- 2023-2187
- Acronym
- AAAhypotension
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The raw data supporting the conclusions of this article will be made available by the authors upon request and can only be shared anonymously. This restriction is due to hospital policies, which prohibit data sharing without clearly defined purposes. Data transfer agreements must be in place before data can be shared.
Publications
References: 1. Pereira BMT, Chiara O, Ramponi F, Weber DG, Cimbanassi S, De Simone B, et al. WSES position paper on vascular emergency surgery. World J Emerg Surg. 2015 Dec;10(1):49. 2. Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, et al. Abdominal aortic aneurysms. Nat Rev Dis Primer. 2018 Dec;4(1):34. 3. Carino D, Sarac T, Ziganshin B, Elefteriades J. Abdominal Aortic Aneurysm: Evolving Controversies and Uncertainties. Int J Angiol. 2018 Jun;27(02):058-80. 4. van Schaik TG, Yeung KK, Verhagen HJ, de Bruin JL, van Sambeek MRHM, Balm R, et al. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2017 Nov;66(5):1379-89. 5. Lederle FA. Outcomes Following Endovascular vs Open Repair of Abdominal Aortic AneurysmA Randomized Trial. JAMA. 2009 Oct 14;302(14):1535. 6. Veith FJ, Lachat M, Mayer D, Malina M, Holst J, Mehta M, et al. Collected World and Single Center Experience With Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms. Ann Surg. 2009 Nov;250(5):818-24. 7. Patel R, Sweeting MJ, Powell JT, Greenhalgh RM. Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial. The Lancet. 2016 Nov;388(10058):2366-74. 8. Latz CA, Boitano L, Schwartz S, Swerdlow N, Dansey K, Varkevisser RRB, et al. Contemporary mortality after emergent open repair of complex abdominal aortic aneurysms. J Vasc Surg. 2021 Jan;73(1):39-47.e1. 9. Sprung J, Levy PJ, Tabares AH, Gottlieb A, Schoenwald PK, Olin JW. Ischemic liver dysfunction after elective repair of infrarenal aortic aneurysm: Incidence and outcome. J Cardiothorac Vasc Anesth. 1998 Oct;12(5):507-11. 10. Davidovic LB, Maksic M, Koncar I, Ilic N, Dragas M, Fatic N, et al. Open Repair of AAA in a High Volume Center. World J Surg. 2017 Mar;41(3):884-91. 11. Ilic N, Zlatanovic P, Koncar I, Dragas M, Muta
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Perioperative Hypotension After Abdominal Aortic Aneurysm Repair and Its Impact on Early Survival
- ClinicalTrials.gov ID
- NCT07511101
- Acronym / sponsor ID
- AAAhypotension / 2023-2187
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, Intraoperative Hypotension, Postoperative Hypotension, Endovascular Aneurysm Repair, Open Aneurysm Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 6 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.
Background: An abdominal aortic aneurysm (AAA) is a localized dilatation of the infrarenal aorta that, when it meets critical criteria, can rupture and cause a vital emergency, requiring immediate surgery with a mortality rate close to 85%(1). Also, symptomatic AAA and/or imminent rupture is a surgical emergency that should be recognized and treated promptly. Elective procedures are usually performed in patients with AAA with a diameter greater than 5.5 cm in men and 5.0 cm in women(2,3).
There are different techniques for the surgical repair of AAA, which are divided into two main groups: endovascular and open procedures. The endovascular procedure offers an early survival benefit, better postoperative recovery, and fewer incision-related complications as it is a minimally invasive procedure. However, it requires more re-interventions, but most are mainly minor endovascular procedures. In contrast, an open approach has a better 15-year late survival benefit, associated with greater graft durability, a lower rate of re-interventions, and the additional advantage of being more affordable (4-7).
Several risk factors have been established around surgical procedures that may affect the outcome, including preoperative and intraoperative hypotension. Preoperative hypotension is one of the most crucial factors, especially when talking about ruptured AAA, where it is present with a high frequency and has been seen as an association with mortality with an AOR of 3.28 (CI 1.75-5.41; P < .001) (8). For intraoperative hypotension, a study showed that it increased the 30-day mortality after an elective open repair of AAA with an OR of 6.61 (CI 0.71-61.07; p = 0.05). Also, it has been associated with liver dysfunction (p < 0.001) and colonic ischemia (P=0.021) (9-11).
However, the frequency and effects of postoperative hypotension in open and endovascular AAA surgery have not been described in the literature despite the everyday use of vasopressor medications (48%) in the immediate medical management following an open AAA repair(12). However, other studies have shown that postoperative hypotension in abdominal surgery is a significant complication that can have adverse effects on the patient. This condition is characterized by a decrease in blood pressure, which can lead to myocardial injury, acute kidney damage, and an increase in short-term mortality(13).
According to literature, postoperative hypotension is common after major abdominal surgeries, and its detection may be suboptimal if routine vital sign assessments are the sole monitoring method. A prospective observational study found that nearly one-quarter of patients experienced episodes of mean arterial pressure (MAP) below 70 mmHg for at least 30 minutes, many of which went undetected through routine evaluations(14). Another study highlighted that prolonged postoperative hypotension, defined by absolute MAP thresholds, is associated with myocardial injury, especially when MAP falls below 65 mmHg for extended periods (15).
In addition, in other vascular interventions like carotid endarterectomy, postoperative hypotension has been associated with increased risks of 30-day mortality, stroke, myocardial infarction, and length of stay(16).
Given the potential implications for adverse perioperative outcomes, it is essential to elucidate potential risk factors to tailor the perioperative management of AAA repair further. Thus, we aim to describe the mortality and determine the risk factors associated with peroperative and postoperative hypotension at 48 hours in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 1-1-2013 until 31-12-2021.
Research question: What were the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 to 2021?
Hypothesis:
Alternate hypothesis: There are specific risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 until 2021.
Detailed description
Research design: Observational, monocenter, retrospective cohort study.
Selection Criteria:
- Inclusion criteria: all patients treated open and endovascular for an abdominal aortic aneurysm in Rijnstate between 1-1-2013 and 31-12-2021.
- Exclusion criteria: Patients managed hybrid (EVAR + open) or expectantly.
Objectives:
General Objective: Determine the risk factors associated with per- and postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital from 1-1-2013 until 31-12-2021.
- Specific Objectives:
- Characterize the sociodemographic and clinical variables of the patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
- Determine the risk factors associated with peroperative and postoperative hypotension in patients who underwent an Infrarenal elective open Abdominal Aortic Aneurysm Repair.
- Determine the risk factors associated with peroperative and postoperative hypotension in patients who underwent an Infrarenal elective endovascular Abdominal Aortic Aneurysm Repair.
- Describe the 30-day postoperative mortality associated with each type of management and postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
- Describe the 30-day postoperative secondary clinical outcomes associated with each type of management and postoperative Hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
Analysis unit
The unit of analysis for this study will be mortality as the dependent variable and the presence of peropertive and postoperative hypotension at 48 hours, defined as an SBP less than 90 mmHg, a MAP less than 60 mmHg, or a difference of more than 30 mmHg compared to pre-operative blood pressure (17).
Additionally, the secondary outcomes will include the occurrence of acute kidney injury, acute myocardial infarction, prolonged mechanical ventilation, spinal cord ischemia, stroke, and mesenteric ischemia (13).
Statistical Analysis: The description of the variables will be done by calculating absolute and relative frequencies for qualitative variables and the use of measures of central tendency and dispersion for quantitative variables; parametric and nonparametric statistics will be used depending on the normal distribution of the data, which will be evaluated using Kolmogorov-Smirnov or Shapiro-Wilk.
Bivariate analysis will be performed, the student t-test will be used for normally distributed data, and the Mann-Whitney U and Kruskal-Wallis H tests will be used for non-normally distributed data. Rates and differences in proportions will be estimated using Pearson's c2 test and Fisher's exact test.
Subsequently, a Kaplan-Meier survival analysis will be performed to evaluate mortality up to 30 days after the surgical procedure or until discharge. Sensitivity analyses will be used to calculate survival. Missing values will be excluded from the analysis. A P value of < 0.05 will be considered statistically significant.
A univariate and multivariate logistic regression analysis will study the association between hypotension and risk factors.
Data management:
Each investigator involved in this research project will be responsible for ensuring the protection and security of patient data. Once the final research products have been generated, the principal investigator will be responsible for the final custody of the database and directory of variables.
Bias control: The potential measures of bias for this study and the control strategy for each are:
- Information bias: The possibility that patients do not have all the information necessary to complete the database and incur loss of information should be contemplated. If the clinical history does not contain all the information needed to complete the database, Missing values will be excluded from the analysis.
- Observer bias: This bias can occur when the researcher, knowing the expected outcome, tends to find more cases of this event in a particular cohort. A non-existent association may appear. To avoid this, only the information found in the clinical history or reliable and objective sources of information will be included without interpretation of any variable by the investigators.
- Confounding bias: All results derived from observational studies are potentially influenced by confounding bias. In this type of study confounding bias is understood as a comparability problem whose origin is linked to the impossibility of randomly assigning the exposure of the study subjects. Thus, confounding variables are not equally distributed among the contrast groups, and subjects are exposed for different reasons that depend on cultural and socioeconomic patterns. To reduce the risk of the presence of this bias, different risk factors associated with worse outcomes have been included so that the analysis can control for these factors in case there is a greater presence of these factors in some of the groups that could affect the results.
Expected Results and Impact: Publish one paper with the institutional experience to generate knowledge on this pathology's multidisciplinary management and present an abstract at an international congress.
- Determine the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair.
- Describe the mortality and secondary clinical outcomes associated with each type of treatment and postoperative hypotension in patients undergoing infrarenal abdominal aortic aneurysm repair.
Ethical aspects: The study is conducted within the ethical principles for medical research on human subjects according to the Declaration of Helsinki - 59th General Assembly, Seoul, Korea, October 2008. CIOMS Guidelines, the Good Clinical Practice Guidelines of the International Conference on Harmonization (GCP/ICH). The present research is classified within the category of no risk. Since it is a retrospective study in which no intervention will be performed.
Access to the research instruments will be limited only to the investigators, who will be ready to give information about the study to organized, approved, and interested entities if they are of an academic and scientific nature, preserving the accuracy of the results. Absolute confidentiality will be maintained, and a good professional, institutional name will be preserved.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-complex AAA repair | – | –Patients treated with standard EVAR |
| Complex AAA repair | – | –Patients treated by complex endovascular or open AAA repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an abdominal aortic aneurysm treated electively between 2013 and 2022.
Key inclusion criteria (2 listed)
- Age > 18 years
- Elective AAA repair between 2013 and 2022 (endovascular and open)
Key exclusion criteria (7 listed)
- Data from the blood pressure monitoring system were only available from 2013, so patients treated before January 1th 2013 were excluded.
- Patients were also excluded from the study if registered objection to use their data for research,
- absence of blood pressure data,
- revision surgery after previous endovascular or open repair,
- ruptured aneurysm,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day survival
Time frame: 30 days
30-day survival
3 secondary outcomes
1-year survival
Time frame: 1-year
Prevalence intra-operative hypotension
Time frame: peri-operative
Prevalence post-operative hypotension
Time frame: until 48 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- BackgroundReferences: 1. Pereira BMT, Chiara O, Ramponi F, Weber DG, Cimbanassi S, De Simone B, et al. WSES position paper on vascular emergency surgery. World J Emerg Surg. 2015 Dec;10(1):49. 2. Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, et al. Abdominal aortic aneurysms. Nat Rev Dis Primer. 2018 Dec;4(1):34. 3. Carino D, Sarac T, Ziganshin B, Elefteriades J. Abdominal Aortic Aneurysm: Evolving Controversies and Uncertainties. Int J Angiol. 2018 Jun;27(02):058-80. 4. van Schaik TG, Yeung KK, Verhagen HJ, de Bruin JL, van Sambeek MRHM, Balm R, et al. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2017 Nov;66(5):1379-89. 5. Lederle FA. Outcomes Following Endovascular vs Open Repair of Abdominal Aortic AneurysmA Randomized Trial. JAMA. 2009 Oct 14;302(14):1535. 6. Veith FJ, Lachat M, Mayer D, Malina M, Holst J, Mehta M, et al. Collected World and Single Center Experience With Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms. Ann Surg. 2009 Nov;250(5):818-24. 7. Patel R, Sweeting MJ, Powell JT, Greenhalgh RM. Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial. The Lancet. 2016 Nov;388(10058):2366-74. 8. Latz CA, Boitano L, Schwartz S, Swerdlow N, Dansey K, Varkevisser RRB, et al. Contemporary mortality after emergent open repair of complex abdominal aortic aneurysms. J Vasc Surg. 2021 Jan;73(1):39-47.e1. 9. Sprung J, Levy PJ, Tabares AH, Gottlieb A, Schoenwald PK, Olin JW. Ischemic liver dysfunction after elective repair of infrarenal aortic aneurysm: Incidence and outcome. J Cardiothorac Vasc Anesth. 1998 Oct;12(5):507-11. 10. Davidovic LB, Maksic M, Koncar I, Ilic N, Dragas M, Fatic N, et al. Open Repair of AAA in a High Volume Center. World J Surg. 2017 Mar;41(3):884-91. 11. Ilic N, Zlatanovic P, Koncar I, Dragas M, Muta
- Individual participant dataSharing planned: Undecided. The raw data supporting the conclusions of this article will be made available by the authors upon request and can only be shared anonymously. This restriction is due to hospital policies, which prohibit data sharing without clearly defined purposes. Data transfer agreements must be in place before data can be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AAA - Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-day survival (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07511101, which also lists 1 linked publication.
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 13 Apr 2026.