Clinical trial NCT04754659: Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Official title: Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Renal Insufficiency
Stent-Graft Thrombosis
Keywords: abdominal aortic aneurysm
postoperative renal failure
stentgraft complication
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-02-15
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, parallel group, partly blinded clinical study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with decreased renal function (composite endpoint together with the endpoint below)
timeFrame: Change between baseline renal function and at 3 years.
measure: Number of participants with new renal infarct
timeFrame: Change in numbers of new renal infarcts between baseline and at 3 years.
Secondary outcomes:
measure: 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).
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with decreased score in quality of life-questionnaire
timeFrame: From treatment and 1 and 3 years postoperatively
measure: Number of participants with stentgraft thrombosis
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with aneurysm related mortality
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with aneurysm related hospitalizations
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with continuing aneurysm growth
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with new diagnosis of cancer
timeFrame: From treatment and 1, 3 and 5 years postoperatively
Other outcomes:
measure: Number of participants with migration (Safety endpoint composite together with the endpoints below)
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with diagnosed endoleak
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with aortic rupture
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with renal artery thrombosis
timeFrame: From treatment and 1, 3 and 5 years postoperatively
measure: Number of participants with renal artery stenosis
timeFrame: From treatment and 1, 3 and 5 years postoperatively
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: VastraGotaland
Study officials:
affiliation: Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital
name: Sophie Lindgren, M.D
role: STUDY_CHAIR
References: