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Recruiting NCT04754659

Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

No phase Interventional Aortic Aneurysm, Abdominal Renal Insufficiency Stent-Graft Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stentgraft.
Who it may be relevant to
Registry conditions: Aortic Aneurysm, Abdominal, Renal Insufficiency, Stent-Graft Thrombosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Number of participants with decreased renal function (composite endpoint together with the endpoint below) [Time frame: Change between baseline renal function and at 3 years.]
  • Number of participants with new renal infarct [Time frame: Change in numbers of new renal infarcts between baseline and at 3 years.]
Secondary outcome measures (7)
  • 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). [Time frame: From treatment and 1, 3 and 5 years postoperatively]
  • Number of participants with decreased score in quality of life-questionnaire [Time frame: From treatment and 1 and 3 years postoperatively]
  • Number of participants with stentgraft thrombosis [Time frame: From treatment and 1, 3 and 5 years postoperatively]
  • Number of participants with aneurysm related mortality [Time frame: From treatment and 1, 3 and 5 years postoperatively]
  • Number of participants with aneurysm related hospitalizations [Time frame: From treatment and 1, 3 and 5 years postoperatively]
  • Number of participants with continuing aneurysm growth [Time frame: From treatment and 1, 3 and 5 years postoperatively]
  • Number of participants with new diagnosis of cancer [Time frame: From treatment and 1, 3 and 5 years postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Sahlgrenska University Hospital — Gothenburg

Identifiers

NCT: NCT04754659 · RENOFIX 3.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗