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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
252
Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Sahlgrenska University Hospital
Gothenburg, VastraGotaland, Sweden
RECRUITINGNumber 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.
Time frame: 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
Time frame: Change in numbers of new renal infarcts between baseline and at 3 years.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From treatment and 1, 3 and 5 years postoperatively