Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Aneurysm Abdominal
- Renal Insufficiency
- Stent-Graft Thrombosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled, parallel group, partly blinded clinical study.Masking: Triple (Participant, Investigator, Outcomes 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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, base...
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.
Tracking Information
- NCT #
- NCT04754659
- Collaborators
- Not Provided
- Investigators
- Study Chair: Sophie Lindgren, M.D Department of Hybrid and Interventional Surgery, Sahlgrenska University Hospital
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