Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm (RENOFIX)

Vastra Gotaland Region

Status: Enrolling

Conditions: Stent-Graft Thrombosis; Renal Insufficiency; Aortic Aneurysm, Abdominal

Treatments: Device: Stentgraft

Study type: Interventional

Funder types: Other

Identifiers

NCT04754659

RENOFIX 3.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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252 participants in 2 patient groups

Suprarenal

Experimental group

Description:

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

Treatment:

Device: Stentgraft

Infrarenal

Active Comparator group

Description:

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

Treatment:

Device: Stentgraft