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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Insufficiency; Aortic Aneurysm, Abdominal; Stent-Graft Thrombosis
• Intervention / Treatment: Device: Stentgraft

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.

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Per Skoog, M.D; Phone Number: +46316021000; Email: per.skoog@vgregion.se
• Study Contact Backup: Name: Joakim Nordanstig, M.D; Phone Number: +46316021000; Email: joakim.nordanstig@vgregion.se

Study Locations

• Sweden
  • VastraGotaland
    • Gothenburg, VastraGotaland, Sweden
      • Recruiting
      • Sahlgrenska University Hospital
      • Contact: Per Skoog; Phone Number: +46316021000; Email: per.skoog@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suprarenal; Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA.	Device: Stentgraft; Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Active Comparator: Infrarenal; Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA.	Device: Stentgraft; Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	From treatment and 1, 3 and 5 years postoperatively
Number of participants with decreased score in quality of life-questionnaire	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.	From treatment and 1 and 3 years postoperatively
Number of participants with stentgraft thrombosis	Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with aneurysm related mortality	Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with aneurysm related hospitalizations	Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with continuing aneurysm growth	Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with new diagnosis of cancer	New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with migration (Safety endpoint composite together with the endpoints below)	Migration (stentgraft migration more than 3mm) postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with diagnosed endoleak	Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with aortic rupture	Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with renal artery thrombosis	Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively
Number of participants with renal artery stenosis	Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years.	From treatment and 1, 3 and 5 years postoperatively

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Study Chair: Sophie Lindgren, M.D, Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: abdominal aortic aneurysm; postoperative renal failure; stentgraft complication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Embolism and Thrombosis; Aortic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Thrombosis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: RENOFIX 3.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes