Renal Insufficiency Clinical Trial
— RENOFIXOfficial title:
Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
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.
Status | Recruiting |
Enrollment | 252 |
Est. completion date | December 2027 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | VastraGotaland |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | From treatment and 1, 3 and 5 years postoperatively | |
Other | Number of participants with diagnosed endoleak | Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | |
Other | Number of participants with aortic rupture | Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | |
Other | Number of participants with renal artery thrombosis | Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | |
Other | Number of participants with renal artery stenosis | Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years. | From treatment and 1, 3 and 5 years postoperatively | |
Primary | 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. | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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