Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

NCT04754659 | Recruiting DMC

• 1 other identifier: RENOFIX 3.1
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

abdominal aortic aneurysm; postoperative renal failure; stentgraft complication

Outcome Measures

Primary Outcomes (2)

• Number of participants with decreased renal function (composite endpoint together with the endpoint below)

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

  Change between baseline renal function and at 3 years.

• Number of participants with new renal infarct

  Diagnosed new renal infarct on CT scan after treatment

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

Secondary Outcomes (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).

  From treatment and 1, 3 and 5 years postoperatively

• Number of participants with decreased score in quality of life-questionnaire

  From treatment and 1 and 3 years postoperatively

• Number of participants with stentgraft thrombosis

  From treatment and 1, 3 and 5 years postoperatively

• Number of participants with aneurysm related mortality

  From treatment and 1, 3 and 5 years postoperatively

• Number of participants with aneurysm related hospitalizations

  From treatment and 1, 3 and 5 years postoperatively

Other Outcomes (5)

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

  From treatment and 1, 3 and 5 years postoperatively

• Number of participants with diagnosed endoleak

  From treatment and 1, 3 and 5 years postoperatively

• Number of participants with aortic rupture

  From treatment and 1, 3 and 5 years postoperatively

Study Arms (2)

Suprarenal

EXPERIMENTAL

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

Device: Stentgraft

Infrarenal

ACTIVE COMPARATOR

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

Device: Stentgraft

Interventions

Stentgraft DEVICE

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

Infrarenal; Suprarenal

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, VastraGotaland, Sweden

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Renal Insufficiency

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sophie Lindgren, M.D

  Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital

  STUDY CHAIR

Central Study Contacts

Per Skoog, M.D

CONTACT

+46316021000; per.skoog@vgregion.se

Joakim Nordanstig, M.D

CONTACT

+46316021000; joakim.nordanstig@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled, parallel group, partly blinded clinical study.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 15, 2021
• Study Start: December 19, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)