RENOFIX: Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04754659

Collaborator

(none)

252

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal Renal Insufficiency Stent-Graft Thrombosis	Device: Stentgraft	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled, parallel group, partly blinded clinical study.Randomized controlled, parallel group, partly blinded clinical study.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The type of stentgraft is masked for participants, investigators and outcome assessors as the journal chart and information about implanted device are made not accessible for the above mentioned individuals, and all data will be gathered in an Electronic Case Report Form (eCRF) with stentgraft information masked.

Primary Purpose:

Treatment

Official Title:

Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suprarenal Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA.	Device: Stentgraft Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Active Comparator: Infrarenal Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA.	Device: Stentgraft Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.

Arm

Intervention/Treatment

Experimental: Suprarenal

Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA.

Device: Stentgraft

Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.

Active Comparator: Infrarenal

Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA.

Device: Stentgraft

Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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 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 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.

Other Outcome Measures

Number of participants with migration (Safety endpoint composite together with the endpoints below) [From treatment and 1, 3 and 5 years postoperatively]
Migration (stentgraft migration more than 3mm) postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with diagnosed endoleak [From treatment and 1, 3 and 5 years postoperatively]
Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with aortic rupture [From treatment and 1, 3 and 5 years postoperatively]
Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with renal artery thrombosis [From treatment and 1, 3 and 5 years postoperatively]
Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with renal artery stenosis [From treatment and 1, 3 and 5 years postoperatively]
Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.