Actively Recruiting
Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study
Led by Vastra Gotaland Region · Updated on 2024-05-07
252
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how two different types of stentgraft fixations affect kidney function after treating infrarenal abdominal aortic aneurysm (AAA). The trial compares stentgrafts with active suprarenal fixation to those with infrarenal fixation. This study is a randomized controlled trial including participants from Scandinavia to understand the impact of these treatments on kidney health. Participants are randomly assigned to receive either a suprarenal or infrarenal stentgraft for their AAA. After enrollment, baseline data is collected and randomization occurs. Follow-up visits are planned at 1 month, 1 year, 3 years, and 5 years after treatment. These visits include blood tests to assess kidney function and CT scans to check the stentgraft performance. Health-related quality of life questionnaires are also completed during follow-ups. During the study, participants will undergo regular assessments including blood sample analysis for kidney function and imaging scans to monitor the stentgrafts. Researchers will measure changes in kidney function and look for new kidney infarcts as primary outcomes after 3 years. Secondary outcomes include quality of life changes, stentgraft complications, aneurysm-related events, and new cancer diagnoses. The study also monitors safety and outcomes up to 5 years post-treatment.
CONDITIONS
Brief Title
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Diagnosed with non-ruptured infrarenal or iliac abdominal aortic aneurysm
- Suitable anatomy for treatment with an approved stentgraft device for AAA
- Accepted for endovascular aortic repair (EVAR) by a participating vascular center
You will not qualify if you...
- Currently on dialysis or planning to start dialysis
- Need for stents or stentgrafts in renal or visceral arteries
- Unable to complete health-related quality of life questionnaires due to language barriers
- Anatomical conditions preventing use of both fixation types, including advanced suprarenal tortuosity over 60 degrees, suprarenal dilatation, or infrarenal thrombus covering more than 25% of vessel circumference
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment period as determined by the procedure
Participants are treated with a stentgraft for abdominal aortic aneurysm, using either suprarenal or infrarenal fixation.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants have follow-up visits to assess renal function, stentgraft performance, and quality of life through blood samples, CT scans, and questionnaires.
Follow-up visits at 1 month, 1 year, 3 years, and 5 years post-treatment
Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hospital
Gothenburg, VastraGotaland, Sweden
Actively Recruiting
Research Team
P
Per Skoog, M.D
J
Joakim Nordanstig, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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