Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorVastra Gotaland Region
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Stentgraft
DeviceStentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: SuprarenalExperimental treatment 1 intervention
Group B: InfrarenalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change between baseline renal function and at 3 years.2
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.Secondary outcomes
1
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 postoperatively2
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 postoperatively3
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 postoperatively4
Number of participants with aneurysm related mortality
Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.
Time frame
From treatment and 1, 3 and 5 years postoperativelyOther outcomes
1
Number of participants with migration (Safety endpoint composite together with the endpoints below)
Migration (stentgraft migration more than 3mm) postoperatively at 1 month, 1, 3 and 5 years.
Time frame
From treatment and 1, 3 and 5 years postoperatively2
Number of participants with diagnosed endoleak
Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years.
Time frame
From treatment and 1, 3 and 5 years postoperatively3
Number of participants with aortic rupture
Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years.
Time frame
From treatment and 1, 3 and 5 years postoperatively4
Number of participants with renal artery thrombosis
Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Time frame
From treatment and 1, 3 and 5 years postoperativelySponsors and contacts
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Source ClinicalTrials.gov