Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773223
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2021-02-20
Brief Title:
Comparison of Outcomes of Complex Abdominal Aortic Aneurysm Treatment
Sponsor:
Clinical Centre of Serbia
Organization:
Clinical Centre of Serbia
Study Overview
Official Title:
Comparison of Endovascular and Open Repair of Juxta- and Pararenal Abdominal Aortic Aneurysm on Short- and Long-term Clinical Outcomes
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Open repair remains the gold standard for fit patients with complex AAA In the past decade an evolution of devices design components and delivery systems expanded the application of EVAR in these challenging anatomies Fenestrated stent-grafts are now commercially available for the repair of complex AAA in the United States and Europe Initial reports have demonstrated a high technical success rate low renal dysfunction rate and low morbidity and mortality with promising short- and long-term results Other reports have shown excessive morbidity and mortality with fenestrated EVAR FEVAR Studies comparing endovascular and open repair are sparse especially when it concerns long-term outcomes There are till nowadays only two propensity score-matched studies one showing worse short-term and another long-term clinical outcome for fenestrated-branched EVAR FBEVAR over open surgical repair OSR
Aim The aim of this study will be to compare FBEVAR versus open AAA repair on short- and long-term clinical outcomes for the treatment of juxta- and pararenal AAA
Methodology This is a prospective cohort study from the four high-volume AAA repair centers BelgradeSerbia BolognaItaly MilanItaly DijklanderNetherland AmsterdamNetherland and HelsinkiFinland Data will be collected on demographics baseline comorbidities AAA parameters diameter and localization laboratory values intra- and postoperative data Follow-up examinations clinical visits and color duplex ultrasonography CT scans will be performed 1 6 and 12 months after the intervention and annually thereafter Propensity score analysis will be performed by matching open repair patients to endovascularly treated controlling for demographics and baseline comorbidities
Endpoints Primary endpoints are all-cause mortality and the freedom from aortic-related reintervention The secondary endpoint is the 30-day complication rate especially acute kidney injury according to the RIFLE criteria
Aim The aim of this study will be to compare FBEVAR versus open AAA repair on short- and long-term clinical outcomes for the treatment of juxta- and pararenal AAA
Methodology This is a prospective cohort study from the four high-volume AAA repair centers BelgradeSerbia BolognaItaly MilanItaly DijklanderNetherland AmsterdamNetherland and HelsinkiFinland Data will be collected on demographics baseline comorbidities AAA parameters diameter and localization laboratory values intra- and postoperative data Follow-up examinations clinical visits and color duplex ultrasonography CT scans will be performed 1 6 and 12 months after the intervention and annually thereafter Propensity score analysis will be performed by matching open repair patients to endovascularly treated controlling for demographics and baseline comorbidities
Endpoints Primary endpoints are all-cause mortality and the freedom from aortic-related reintervention The secondary endpoint is the 30-day complication rate especially acute kidney injury according to the RIFLE criteria
Detailed Description:
Background Endovascular abdominal aortic aneurysm repair EVAR has gained widespread acceptance in the treatment of patients with abdominal aortic aneurysms AAA Prospective randomized trials RCTs have demonstrated several short-term advantages over open repair such as less blood loss operative time hospital stay morbidity and mortality The applicability of EVAR is limited by the presence of inadequate neck or involvement of the visceral arteries Thus consequently open AAA repair is now being performed primarily for complex aortic anatomies such as juxtarenal and pararenal aneurysms Open repair remains the gold standard for fit patients with complex AAA In the past decade an evolution of devices design components and delivery systems expanded the application of EVAR in these challenging anatomies Fenestrated stent-grafts are now commercially available for the repair of complex AAA in the United States and Europe Initial reports have demonstrated a high technical success rate low renal dysfunction rate and low morbidity and mortality with promising short- and long-term results Other reports have shown excessive morbidity and mortality with fenestrated EVAR FEVAR Studies comparing endovascular and open repair are sparse especially when it concerns long-term outcomes There are till nowadays only two propensity score-matched studies one showing worse short-term and another long-term clinical outcome for fenestrated-branched EVAR FBEVAR over open surgical repair OSR Vascular surgeons are therefore left with a paucity of data to guide decision-making
Study objectives
1 Primary aim Compare Kaplan-Meier freedom from aortic related reintervention and all-cause mortality rate between endovascular and open repair group Primary endpoint Kaplan-Meier survival rate and Kaplan-Meier aortic related reintervention rate after the patient recruitment ends
2 Secondary aim compare short term outcomes in terms of 30-day complications rate especially acute kidney injury according to the RIFLE criteria Secondary endpoint 30-day complications rate especially acute kidney injury according to the RIFLE criteria
Inclusion criteria
All patients over 18 years of age with a history of juxta- and pararenal AAA repair from January 2011 to January 2021
All management strategies will be included endovascular and open
Exclusion criteria
Patients who are pregnant
Patients who are under 18 years of age
Patients who have ruptured AAA
Patients with thoracoabdominal aortic aneurysm ThAAA
Patients who have a mycotic AAA
Patients with connective tissue disorder
Sample size To ensure sufficient statistical power to answer hypothetical questions approximately 700 subjects will be entered into the database Aortic-related reintervention rate is the primary endpoint being used to calculate the sample size Assuming a difference of 7 in the late reintervention rate between endovascular and open repair 221 patients would be required in each arm to achieve a statistical power of 85 at p005 With two arms endovascular versus open assuming a 20 rate of missing data a total N of 550 patients is required
Research Design
This is a prospective study including patients treated for juxta- and pararenal AAA from 2011 through 2021 treated at six different vascular surgery centers
1 Clinic for Vascular and Endovascular Surgery Belgrade Serbia
2 Department of Vascular Surgery Policlinico S Orsola-Malpighi Bologna Italy
3 Department of Vascular Surgery San Raffaele Hospital Milan Italy
4 Department of Vascular Surgery Dijklander Ziekenhuis Hoorn Netherlands
5 Department of Vascular Surgery Amsterdam University Hospital Amsterdam Netherlands
6 Department of Vascular Surgery Helsinki Unversity Hospital Helsinki Finland
Procedures Involved The study does not involve any patient contact and will not impact the care that patients receive Data regarding the patients will be compiled and analyzed to accomplish the proposed study objectives Data collection will include demographic information patient-related factors and comorbidities diagnostic imaging information laboratory data surgical procedure information complications of the surgery and outcomes
Multi-Institutional research After the data has been collected at a participating institution the data will be transmitted to a central analytic center located at the Clinic for Vascular and Endovascular SurgeryClinical Center of SerbiaMedical Faculty University of Belgrade
Risks to Subjects As this is a prospective observational study there is no potential for physical risks to subjects There is a minimal risk of breach of confidentiality that could occur when patient information is collected and analyzed for the proposed study However appropriate measures will be taken to minimize the risk as much as possible All information recorded will be de-identified This study will abide by all regulations related to protecting human subjects and protected health information
Potential Benefits to Subjects There is no direct benefit to the subjects However future patients with juxta- and pararenal AAA may benefit from improved care as a result of this study
Statistics and Data Analysis Continuous variables will be described using the median and interquartile range or mean and standard deviation Categorical variables will be described using frequencies and percentages Group comparisons will be performed by using the Student t-test or Mann-Whitney U test as appropriate Categorical data will be expressed as percentages and were compared using the chi-square test or Fisher exact test Propensity score analysis will be performed by matching endovascular to open surgery group in a 11 ratio controlling for demographics baseline comorbidities and AAA parameters Differences will be considered statistically significant at p 005 The cumulative incidences of all-cause mortality and aortic-related complications will be estimated using the Kaplan-Meier method Differences between curves will be tested using the log-rank test Analyses will be done with SPSS software version 200 SPSS Chicago IL USA
Conflict of Interest The investigators have no conflict of interest to report
Funding Source There are no plans to apply for grants or additional funding No funding is required for the completion of this study
Publication Plan All research personnel listed on this protocol will be eligible for authorship in any resulting abstracts and publications in accordance with the qualifications outlined by the International Committee of Medical Journal Editors The order of authors will be determined prior to manuscript development and depend on each individuals contribution to the study
Study objectives
1 Primary aim Compare Kaplan-Meier freedom from aortic related reintervention and all-cause mortality rate between endovascular and open repair group Primary endpoint Kaplan-Meier survival rate and Kaplan-Meier aortic related reintervention rate after the patient recruitment ends
2 Secondary aim compare short term outcomes in terms of 30-day complications rate especially acute kidney injury according to the RIFLE criteria Secondary endpoint 30-day complications rate especially acute kidney injury according to the RIFLE criteria
Inclusion criteria
All patients over 18 years of age with a history of juxta- and pararenal AAA repair from January 2011 to January 2021
All management strategies will be included endovascular and open
Exclusion criteria
Patients who are pregnant
Patients who are under 18 years of age
Patients who have ruptured AAA
Patients with thoracoabdominal aortic aneurysm ThAAA
Patients who have a mycotic AAA
Patients with connective tissue disorder
Sample size To ensure sufficient statistical power to answer hypothetical questions approximately 700 subjects will be entered into the database Aortic-related reintervention rate is the primary endpoint being used to calculate the sample size Assuming a difference of 7 in the late reintervention rate between endovascular and open repair 221 patients would be required in each arm to achieve a statistical power of 85 at p005 With two arms endovascular versus open assuming a 20 rate of missing data a total N of 550 patients is required
Research Design
This is a prospective study including patients treated for juxta- and pararenal AAA from 2011 through 2021 treated at six different vascular surgery centers
1 Clinic for Vascular and Endovascular Surgery Belgrade Serbia
2 Department of Vascular Surgery Policlinico S Orsola-Malpighi Bologna Italy
3 Department of Vascular Surgery San Raffaele Hospital Milan Italy
4 Department of Vascular Surgery Dijklander Ziekenhuis Hoorn Netherlands
5 Department of Vascular Surgery Amsterdam University Hospital Amsterdam Netherlands
6 Department of Vascular Surgery Helsinki Unversity Hospital Helsinki Finland
Procedures Involved The study does not involve any patient contact and will not impact the care that patients receive Data regarding the patients will be compiled and analyzed to accomplish the proposed study objectives Data collection will include demographic information patient-related factors and comorbidities diagnostic imaging information laboratory data surgical procedure information complications of the surgery and outcomes
Multi-Institutional research After the data has been collected at a participating institution the data will be transmitted to a central analytic center located at the Clinic for Vascular and Endovascular SurgeryClinical Center of SerbiaMedical Faculty University of Belgrade
Risks to Subjects As this is a prospective observational study there is no potential for physical risks to subjects There is a minimal risk of breach of confidentiality that could occur when patient information is collected and analyzed for the proposed study However appropriate measures will be taken to minimize the risk as much as possible All information recorded will be de-identified This study will abide by all regulations related to protecting human subjects and protected health information
Potential Benefits to Subjects There is no direct benefit to the subjects However future patients with juxta- and pararenal AAA may benefit from improved care as a result of this study
Statistics and Data Analysis Continuous variables will be described using the median and interquartile range or mean and standard deviation Categorical variables will be described using frequencies and percentages Group comparisons will be performed by using the Student t-test or Mann-Whitney U test as appropriate Categorical data will be expressed as percentages and were compared using the chi-square test or Fisher exact test Propensity score analysis will be performed by matching endovascular to open surgery group in a 11 ratio controlling for demographics baseline comorbidities and AAA parameters Differences will be considered statistically significant at p 005 The cumulative incidences of all-cause mortality and aortic-related complications will be estimated using the Kaplan-Meier method Differences between curves will be tested using the log-rank test Analyses will be done with SPSS software version 200 SPSS Chicago IL USA
Conflict of Interest The investigators have no conflict of interest to report
Funding Source There are no plans to apply for grants or additional funding No funding is required for the completion of this study
Publication Plan All research personnel listed on this protocol will be eligible for authorship in any resulting abstracts and publications in accordance with the qualifications outlined by the International Committee of Medical Journal Editors The order of authors will be determined prior to manuscript development and depend on each individuals contribution to the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None