Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Aneurysm, Abdominal Renal Insufficiency Stent-Graft Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled, parallel group, partly blinded clinical study.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Suprarenal

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

Group Type EXPERIMENTAL

Stentgraft

Intervention Type DEVICE

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

Infrarenal

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

Group Type ACTIVE_COMPARATOR

Stentgraft

Intervention Type DEVICE

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

Interventions

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Stentgraft

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes