Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

Renal Insufficiency Clinical Trial

— RENOFIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754659
• Other study ID #: RENOFIX 3.1
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Vastra Gotaland Region
• Contact: Per Skoog, M.D
• Phone: +46316021000
• Email: per.skoog[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	VastraGotaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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