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

May 5, 2024 updated by: Vastra Gotaland Region

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • VastraGotaland
      • Gothenburg, VastraGotaland, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change between baseline renal function and at 3 years.
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
Change in numbers of new renal infarcts between baseline and at 3 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1 and 3 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with migration (Safety endpoint composite together with the endpoints below)
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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
Time Frame: From treatment and 1, 3 and 5 years postoperatively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sophie Lindgren, M.D, Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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