Sahlgrenska University Hospital
Gothenburg, VastraGotaland, Sweden
Location status: Recruiting
NCT Number: NCT04754659
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Gothenburg, VastraGotaland, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Time frame: Change between baseline renal function and at 3 years.
Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment.
Time frame: Change in numbers of new renal infarcts between baseline and at 3 years.
Diagnosed new renal infarct on CT scan after treatment
Time frame: 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).
Time frame: 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.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
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 postoperatively
Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Time frame: From treatment and 1, 3 and 5 years postoperatively
Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years.
Contact information is provided by the study sponsor or research team.
Joakim Nordanstig, M.D
CONTACT
Per Skoog, M.D
CONTACT
Vastra Gotaland Region
Other Gov
Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
Acronym: RENOFIX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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