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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Stentgraft
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring abdominal aortic aneurysm, postoperative renal failure, stentgraft complication

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Suprarenal

Infrarenal

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Number of participants with new renal infarct
Diagnosed new renal infarct on CT scan after treatment

Secondary Outcome Measures

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).
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.
Number of participants with stentgraft thrombosis
Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with aneurysm related mortality
Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with aneurysm related hospitalizations
Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with continuing aneurysm growth
Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years.
Number of participants with new diagnosis of cancer
New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years.

Full Information

First Posted
January 12, 2021
Last Updated
January 3, 2023
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT04754659
Brief Title
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Acronym
RENOFIX
Official Title
Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal, Renal Insufficiency, Stent-Graft Thrombosis
Keywords
abdominal aortic aneurysm, postoperative renal failure, stentgraft complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled, parallel group, partly blinded clinical study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suprarenal
Arm Type
Experimental
Arm Description
Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA.
Arm Title
Infrarenal
Arm Type
Active Comparator
Arm Description
Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA.
Intervention Type
Device
Intervention Name(s)
Stentgraft
Intervention Description
Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
Primary Outcome Measure Information:
Title
Number of participants with decreased renal function (composite endpoint together with the endpoint below)
Description
Decrease of more than 20 percent in estimated Glomerular Filtration Rate (eGFR) after stentgraft treatment.
Time Frame
Change between baseline renal function and at 3 years.
Title
Number of participants with new renal infarct
Description
Diagnosed new renal infarct on CT scan after treatment
Time Frame
Change in numbers of new renal infarcts between baseline and at 3 years.
Secondary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with decreased score in quality of life-questionnaire
Description
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.
Time Frame
From treatment and 1 and 3 years postoperatively
Title
Number of participants with stentgraft thrombosis
Description
Occurence of stentgraft thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with aneurysm related mortality
Description
Aneurysm related mortality postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with aneurysm related hospitalizations
Description
Aneurysm related hospitalizations postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with continuing aneurysm growth
Description
Continuing aneurysm growth postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with new diagnosis of cancer
Description
New diagnosis of cancer postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Other Pre-specified Outcome Measures:
Title
Number of participants with migration (Safety endpoint composite together with the endpoints below)
Description
Migration (stentgraft migration more than 3mm) postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with diagnosed endoleak
Description
Re-intervention for endoleak postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with aortic rupture
Description
Occurence of postoperative aortic rupture postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with renal artery thrombosis
Description
Postoperative renal artery thrombosis postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively
Title
Number of participants with renal artery stenosis
Description
Occurence of postoperative renal artery stenosis postoperatively at 1 month, 1, 3 and 5 years.
Time Frame
From treatment and 1, 3 and 5 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per Skoog, M.D
Phone
+46316021000
Email
per.skoog@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Joakim Nordanstig, M.D
Phone
+46316021000
Email
joakim.nordanstig@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Lindgren, M.D
Organizational Affiliation
Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
VastraGotaland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Skoog
Phone
+46316021000
Email
per.skoog@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

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