Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
- Conditions
- Stent-Graft ThrombosisRenal InsufficiencyAortic Aneurysm, Abdominal
- Interventions
- Device: Stentgraft
- Registration Number
- NCT04754659
- Lead Sponsor
- Vastra Gotaland Region
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 252
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suprarenal Stentgraft Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA. Infrarenal Stentgraft Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA.
- Primary Outcome Measures
Name Time Method Number of participants with decreased renal function (composite endpoint together with the endpoint below) Change between baseline renal function and at 3 years. Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment.
Number of participants with new renal infarct Change in numbers of new renal infarcts between baseline and at 3 years. Diagnosed new renal infarct on CT scan after treatment
- Secondary Outcome Measures
Name Time Method Number of participants with aneurysm related mortality From treatment and 1, 3 and 5 years postoperatively Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with continuing aneurysm growth From treatment and 1, 3 and 5 years postoperatively Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 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). From treatment and 1, 3 and 5 years postoperatively 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).
Number of participants with stentgraft thrombosis From treatment and 1, 3 and 5 years postoperatively Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with decreased score in quality of life-questionnaire From treatment and 1 and 3 years postoperatively 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.
Number of participants with aneurysm related hospitalizations From treatment and 1, 3 and 5 years postoperatively Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with new diagnosis of cancer From treatment and 1, 3 and 5 years postoperatively New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years.
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, VastraGotaland, Sweden