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NCT Number: NCT04754659

Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, VastraGotaland, Sweden

Location status: Recruiting

Location contact

Per Skoog

CONTACT

[email protected]

+46316021000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stentgraft

Device

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

Primary outcomes

  1. 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.

    Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment.

  2. Number of participants with new renal infarct

    Time frame: Change in numbers of new renal infarcts between baseline and at 3 years.

    Diagnosed new renal infarct on CT scan after treatment

Secondary outcomes

  1. 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

    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).

  2. Number of participants with decreased score in quality of life-questionnaire

    Time frame: 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.

  3. Number of participants with stentgraft thrombosis

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years.

  4. Number of participants with aneurysm related mortality

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.

  5. Number of participants with aneurysm related hospitalizations

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years.

  6. Number of participants with continuing aneurysm growth

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years.

  7. Number of participants with new diagnosis of cancer

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years.

Other outcomes

  1. Number of participants with migration (Safety endpoint composite together with the endpoints below)

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Migration (stentgraft migration more than 3mm) postoperatively at 1 month, 1, 3 and 5 years.

  2. Number of participants with diagnosed endoleak

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years.

  3. Number of participants with aortic rupture

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years.

  4. Number of participants with renal artery thrombosis

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years.

  5. Number of participants with renal artery stenosis

    Time frame: From treatment and 1, 3 and 5 years postoperatively

    Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Joakim Nordanstig, M.D

CONTACT

[email protected]

+46316021000

Per Skoog, M.D

CONTACT

[email protected]

+46316021000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: RENOFIX

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Feb 15, 2021
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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