Aortic Aneurysm, AbdominalRENOFIXNCT04754659
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
A study testing Stentgraft in people with Aortic Aneurysm, Abdominal and Renal Insufficiency, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Abdominal, Renal Insufficiency, Stent-Graft Thrombosis
- What is being tested?
- Stentgraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSweden
- Study dates
- 19 Dec 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, VastraGotaland
Per Skoog, +46316021000, per.skoog@vgregion.se
About this study
Official title: 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.
Read the 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.
- Being tested
- Stentgraft
- Keywords
- abdominal aortic aneurysm, postoperative renal failure, stentgraft complication
- Medical subject headings
- Aortic Aneurysm, Abdominal, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentgraftDevice
Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
| Study group | Role | What they receive |
|---|---|---|
| Suprarenal | Experimental | Individuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA. Receives: Device: Stentgraft |
| Infrarenal | Active comparator | Individuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA. Receives: Device: Stentgraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From treatment and 1, 3 and 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start19 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, parallel group, partly blinded clinical study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sophie Lindgren, M.D, Study chair, Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754659
- Sponsor's protocol ID
- RENOFIX 3.1
- Acronym
- RENOFIX
- Status last verified
- May 2024
- First submitted
- 12 Jan 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04754659
- Acronym / sponsor ID
- RENOFIX / RENOFIX 3.1
- Keywords
- abdominal aortic aneurysm, postoperative renal failure, stentgraft complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled, parallel group, partly blinded clinical study.
| Arm | Type | Receives |
|---|---|---|
| Suprarenal | Experimental | Device: StentgraftIndividuals that are treated with a suprarenal stentgraft for a previously diagnosed AAA. |
| Infrarenal | Active comparator | Device: StentgraftIndividuals that are treated with an infrarenal stentgraft for a previously diagnosed AAA. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StentgraftStentgraft treatment for AAA. Comparison between supra vs infrarenal fixation. | Device | Infrarenal, Suprarenal |
Primary outcome
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.
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
7 secondary outcomes
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
Number of participants with decreased score in quality of life-questionnaire
Time frame: From treatment and 1 and 3 years postoperatively
Number of participants with stentgraft thrombosis
Time frame: From treatment and 1, 3 and 5 years postoperatively
Number of participants with aneurysm related mortality
Time frame: From treatment and 1, 3 and 5 years postoperatively
Number of participants with aneurysm related hospitalizations
Time frame: From treatment and 1, 3 and 5 years postoperatively
Number of participants with continuing aneurysm growth
Time frame: From treatment and 1, 3 and 5 years postoperatively
Number of participants with new diagnosis of cancer
Time frame: From treatment and 1, 3 and 5 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Lindgren, M.D study chair
Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stentgraft in people with Aortic Aneurysm, Abdominal and Renal Insufficiency, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Per Skoog, M.D (+46316021000, per.skoog@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.