Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06253312
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-02
Brief Title:
Treatment of TASC C and D Aortoiliac Lesions
Sponsor:
Clinical Centre of Serbia
Organization:
Clinical Centre of Serbia
Study Overview
Official Title:
Comparison of Open Surgery Hybrid and Endovascular Repair for Complex TASC CD Aortoiliac Lesions
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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
The treatment of patients with complex aortoiliac disease AID classified as Trans-Atlantic Inter-Society consensus II TASC class C and D presents a dilemma for vascular surgeons Current guidelines recommend either open surgical reconstruction OR hybrid repair HR combining iliac stenting with femoral endarterectomy or total endovascular repair ER While traditional OR with aortobifemoral bypass ABF is associated with excellent long term patency results it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8 The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk given the substantially less perioperative morbidity and mortality compared to OR
Aim
The aim of this trial is to evaluate the short mid- and long-term results of open repair hybrid and endovascular repair in the treatment patients with complex TASC C and D aortoiliac lesions
Methodology
This is a retrospective cohort study planning to include vascular surgery centers from the following countries Italy Portugal Spain and Serbia Data will be collected on demographics baseline comorbidities anatomy and morphology of the aortoiliac and femoral bifurcation disease intraoperative postoperative and follow-up data Propensity score analysis will be performed by matching open repair patients in all three groups open hybrid and endovascular repair controlling for demographics baseline comorbidities anatomical and morphological data
Endpoints
Primary endpoints are all-cause mortality and the major adverse limb events major amputation - below and above the knee new onset acute limb ischaemia reintervention of the treated arterial segment The secondary endpoints are the 30-day complications and primary patency
The treatment of patients with complex aortoiliac disease AID classified as Trans-Atlantic Inter-Society consensus II TASC class C and D presents a dilemma for vascular surgeons Current guidelines recommend either open surgical reconstruction OR hybrid repair HR combining iliac stenting with femoral endarterectomy or total endovascular repair ER While traditional OR with aortobifemoral bypass ABF is associated with excellent long term patency results it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8 The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk given the substantially less perioperative morbidity and mortality compared to OR
Aim
The aim of this trial is to evaluate the short mid- and long-term results of open repair hybrid and endovascular repair in the treatment patients with complex TASC C and D aortoiliac lesions
Methodology
This is a retrospective cohort study planning to include vascular surgery centers from the following countries Italy Portugal Spain and Serbia Data will be collected on demographics baseline comorbidities anatomy and morphology of the aortoiliac and femoral bifurcation disease intraoperative postoperative and follow-up data Propensity score analysis will be performed by matching open repair patients in all three groups open hybrid and endovascular repair controlling for demographics baseline comorbidities anatomical and morphological data
Endpoints
Primary endpoints are all-cause mortality and the major adverse limb events major amputation - below and above the knee new onset acute limb ischaemia reintervention of the treated arterial segment The secondary endpoints are the 30-day complications and primary patency
Detailed Description:
Background
The treatment of patients with complex aortoiliac disease AID classified as Trans-Atlantic Inter-Society consensus II TASC class C and D presents a dilemma for vascular surgeons Current guidelines recommend either open surgical reconstruction OR hybrid repair HR combining iliac stenting with femoral endarterectomy or total endovascular repair ER While traditional OR with aortobifemoral bypass ABF is associated with excellent long term patency results 85-90 at five years and 75-80 at ten years it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8 HR has evolved as an attractive minimally invasive alternative to OR especially if the disease extends to the femoral bifurcation with the potential advantages of lower perioperative morbidity and a shorter hospital stay On the other hand ER offers an attractive alternative with durable results five-year primary and secondary patency rates ranging from 60 to 86 and 80 to 98 respectively especially in less extensive AID When combined with low perioperative morbidity it makes ER generally preferable for patients with more severe co-morbid conditions Thus surgical approaches for extensive AID have changed considerably over the last years primarily due to increased ER The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk given the substantially less perioperative morbidity and mortality compared to OR However currently there are no randomized control trials nor large observational trials comparing these treatment option for complex TASC C and D aortoiliac lesions Vascular surgeons are therefore left with a paucity of data to guide decision-making
Sample size
To ensure sufficient statistical power to answer hypothetical questions approximately 900 subjects will be entered into the database Major adverse limb event rate is the primary endpoint being used to calculate the sample size Assuming a difference in terms of MALE 243 patients would be required in each arm to achieve a statistical power of 85 at p005 With three arms endovascular versus open assuming a 20 rate of missing data a total N of 875 patients is required
Research Design
This is a retrospective study including patients with peripheral arterial disease all Rutherford stages treated for TASC CD aortoiliac lesion from January 1st 2015 until January 1st 2022 in four European countries Italy Portugal Spain and Serbia
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 describing the morphology of aortoiliac segment and femoral bifurcation laboratory data surgical procedure information complications of the surgery short- and long-term clinical outcomes
Multi-Institutional research
After the data has been collected at a participating institution the data will be transmitted to online database which will be available only to a central analytic center located at the Clinic for Vascular and Endovascular SurgeryUniversity Clinical Center of SerbiaMedical Faculty University of Belgrade
Risks to Subjects
As this is a retrospective observational study with prospective character 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 treated with complex TASC CD aortoiliac lesions where every treatment option is feasible 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 OR HR and ER group in a 111 ratio controlling for demographics baseline comorbidities and imagining parameters Differences will be considered statistically significant at p 005 The cumulative incidences of all-cause mortality MALE and primary patency rates will be estimated using the Kaplan-Meier method Differences between curves will be tested using the log-rank test Binary outcomes will be evaluated first by univariable methods with results reported as odds ratio OR with 95 confidence intervals CI A multiple logistic regression model will be built including significant co-variables and confounders based on univariable screen p 01 or because of clinical significance A multivariable Cox proportional hazard will be used to assess independent predictors for long-term outcomes with results reported as hazard ratio HR with 95 CI Covariables for these models will be selected based on previously described risk factors and the univariable screen of all available potential confounders Analyses will be done with SPSS software version 280 SPSS Chicago ILLINOIS 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 included in this project 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
The treatment of patients with complex aortoiliac disease AID classified as Trans-Atlantic Inter-Society consensus II TASC class C and D presents a dilemma for vascular surgeons Current guidelines recommend either open surgical reconstruction OR hybrid repair HR combining iliac stenting with femoral endarterectomy or total endovascular repair ER While traditional OR with aortobifemoral bypass ABF is associated with excellent long term patency results 85-90 at five years and 75-80 at ten years it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8 HR has evolved as an attractive minimally invasive alternative to OR especially if the disease extends to the femoral bifurcation with the potential advantages of lower perioperative morbidity and a shorter hospital stay On the other hand ER offers an attractive alternative with durable results five-year primary and secondary patency rates ranging from 60 to 86 and 80 to 98 respectively especially in less extensive AID When combined with low perioperative morbidity it makes ER generally preferable for patients with more severe co-morbid conditions Thus surgical approaches for extensive AID have changed considerably over the last years primarily due to increased ER The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk given the substantially less perioperative morbidity and mortality compared to OR However currently there are no randomized control trials nor large observational trials comparing these treatment option for complex TASC C and D aortoiliac lesions Vascular surgeons are therefore left with a paucity of data to guide decision-making
Sample size
To ensure sufficient statistical power to answer hypothetical questions approximately 900 subjects will be entered into the database Major adverse limb event rate is the primary endpoint being used to calculate the sample size Assuming a difference in terms of MALE 243 patients would be required in each arm to achieve a statistical power of 85 at p005 With three arms endovascular versus open assuming a 20 rate of missing data a total N of 875 patients is required
Research Design
This is a retrospective study including patients with peripheral arterial disease all Rutherford stages treated for TASC CD aortoiliac lesion from January 1st 2015 until January 1st 2022 in four European countries Italy Portugal Spain and Serbia
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 describing the morphology of aortoiliac segment and femoral bifurcation laboratory data surgical procedure information complications of the surgery short- and long-term clinical outcomes
Multi-Institutional research
After the data has been collected at a participating institution the data will be transmitted to online database which will be available only to a central analytic center located at the Clinic for Vascular and Endovascular SurgeryUniversity Clinical Center of SerbiaMedical Faculty University of Belgrade
Risks to Subjects
As this is a retrospective observational study with prospective character 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 treated with complex TASC CD aortoiliac lesions where every treatment option is feasible 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 OR HR and ER group in a 111 ratio controlling for demographics baseline comorbidities and imagining parameters Differences will be considered statistically significant at p 005 The cumulative incidences of all-cause mortality MALE and primary patency rates will be estimated using the Kaplan-Meier method Differences between curves will be tested using the log-rank test Binary outcomes will be evaluated first by univariable methods with results reported as odds ratio OR with 95 confidence intervals CI A multiple logistic regression model will be built including significant co-variables and confounders based on univariable screen p 01 or because of clinical significance A multivariable Cox proportional hazard will be used to assess independent predictors for long-term outcomes with results reported as hazard ratio HR with 95 CI Covariables for these models will be selected based on previously described risk factors and the univariable screen of all available potential confounders Analyses will be done with SPSS software version 280 SPSS Chicago ILLINOIS 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 included in this project 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