Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

Study Overview
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Brief Summary
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This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.

Detailed Description
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This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm with stentgrafts either with active supra- or infrarenal fixation. Individuals are planned to be included throughout Scandinavia. After inclusion in the study, baseline data is collected and computerized randomization between the two stent graft fixation types is performed. Follow-up will be scheduled after 1 month and 1,3 and 5 years. Analyses of blood samples to determine renal function are undertaken together with CT scans to detect stentgraft performance at all follow-up visits alongside assessments of health-related quality of life questionnaires.

Official Title
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Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study

Conditions
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Aortic Aneurysm, Abdominal, Renal Insufficiency, Stent-Graft Thrombosis

Intervention / Treatment
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* Device: Stentgraft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent Meet criteria for non-ruptured infrarenal/iliac aneurysm Suitable anatomy for treatment with an approved device (CE-marked) stentgraft according to the manufacturers' instructions for use for AAA. Accepted for treatment with endovascular aortic repair (EVAR) by the participating vascular center. Exclusion Criteria: Ongoing or planned dialysis AAA treatment requiring stents or stentgrafts in renal and/or visceral arteries Inability to independently complete HRQoL questionnaires due to language barriers Anatomical preconditions that do not allow both types of fixation to be used interchangeably, i.e. very advanced suprarenal tortuosity (>60 degrees), advanced suprarenal dilatation or infrarenal thrombus >25% of circumference.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled, parallel group, partly blinded clinical study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprarenal<br>Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA. | Device: Stentgraft<br>* Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.<br>|
| Active Comparator: Infrarenal<br>Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA. | Device: Stentgraft<br>* Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with decreased renal function (composite endpoint together with the endpoint below) | Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment. | Change between baseline renal function and at 3 years. | 
| Number of participants with new renal infarct | Diagnosed new renal infarct on CT scan after treatment | Change in numbers of new renal infarcts between baseline and at 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with decreased renal function and new renal infarct (Analysis of the individual components of the primary composite endpoint at 1, 3 and 5 years). | Analysis of individual endpoints (decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment and diagnosed new renal infarct on CT scan after treatment). | From treatment and 1, 3 and 5 years postoperatively | 
| Number of participants with decreased score in quality of life-questionnaire | Change in life quality questionnaire (Research and development questionnaire 36 (RAND-36)) one and three years after surgery compared with baseline data collected prior to surgery. Score in the scale are between 0 and 100 and decreased score indicate worse outcome. | From treatment and 1 and 3 years postoperatively | 
| Number of participants with stentgraft thrombosis | Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | 
| Number of participants with aneurysm related mortality | Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | 
| Number of participants with aneurysm related hospitalizations | Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | 
| Number of participants with continuing aneurysm growth | Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | 
| Number of participants with new diagnosis of cancer | New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal aortic aneurysm, postoperative renal failure, stentgraft complication