Contrast Strategy In Fenestrated EndoVascular Aneurysm Repair Randomized Control Trial
This study is investigating different types of contrast dyes used during a special 'keyhole' operation, called FEVAR, to fix a bulge in the body's main artery (aortic aneurysm). We want to find out which contrast dye is safest for your kidneys. Doctors use these dyes and X-rays to see inside your body during the operation. We'll be comparing several widely used dyes to see their effects on kidney health after surgery. The study will also look at how well doctors can see during the surgery, how much radiation is used, and overall patient recovery and quality of life for up to three years after the procedure.
At a glance
What is this study about?
Imagine your body's main artery, the aorta, gets a weak spot and starts to bulge like a balloon. This is called an abdominal aortic aneurysm. If it grows too large, it can be dangerous. One way doctors can fix this is with an operation called FEVAR (Fenestrated EndoVascular Aneurysm Repair). It's a special type of 'keyhole' surgery where doctors use thin tubes and wires, guided by X-rays, to place a special graft inside the artery to fix the bulge.
During this X-ray-guided surgery, doctors need to inject a special liquid called a 'contrast dye' into your blood. This dye makes your blood vessels show up clearly on the X-ray screen, helping the doctors see exactly where they are working. However, sometimes these dyes can put a strain on your kidneys, especially if your kidneys are already a bit weak. This study is like a careful comparison test for different contrast dyes. We want to find out if certain dyes are better or safer for your kidneys than others, while still allowing doctors to see clearly during the operation.
So, this research is important because it aims to help doctors choose the safest contrast dye for patients undergoing this crucial surgery. We'll be looking closely at how patients' kidneys fare after the operation, their overall recovery, and their quality of life over several years. This will help improve care for people needing this type of surgery in the future.
Key takeaways
- This study compares different X-ray dyes used in FEVAR surgery.
- The main goal is to find out which dye is safest for your kidneys.
- Participation involves receiving one of the standard dyes during surgery.
- Your kidney health and general well-being will be monitored for up to 3 years.
- The findings will help improve future care for patients with aortic aneurysms.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older, and there's no upper age limit. The study is open to both men and women.
The main thing is that you have been diagnosed with an abdominal aortic aneurysm and your doctors have decided that the FEVAR 'keyhole' surgery is the right treatment for you. This study is specifically designed for people undergoing this particular type of repair.
Your medical team will check other details of your health to make sure this study is safe and suitable for you. They will explain everything clearly before you make any decisions.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with an abdominal aortic aneurysm?
- Has your doctor recommended FEVAR surgery for you?
- Are you able to attend follow-up appointments for up to 3 years?
What does participation involve?
If you join this study, you will receive one of the study contrast dyes during your planned FEVAR 'keyhole' surgery for your abdominal aortic aneurysm. The specific dye you receive will be chosen randomly, like flipping a coin. You won't know which dye you're getting, nor will your doctors, to ensure fair results.
Before your surgery, you'll have some health checks and fill out questionnaires about your quality of life. After your surgery, the research team will closely monitor your kidney function through blood and urine tests in the days following the operation. They will also assess how well the surgery went using imaging scans and check for any side effects.
You will have follow-up appointments, including scans and questionnaires, at 1 month, and then yearly for up to 3 years after your surgery. These appointments will assess your kidney health, general well-being, the success of the repair, and your overall quality of life. The total duration of your participation, including follow-up, could be up to 3 years.
Potential risks and benefits
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Common questions
What is an abdominal aortic aneurysm?
It's a bulge or weak spot in the main blood vessel that carries blood from your heart to the rest of your body.
What is FEVAR surgery?
It's a 'keyhole' operation where doctors fix the aneurysm using special tubes and a graft, guided by X-rays.
Why do they use 'contrast dye'?
The dye helps doctors see your blood vessels clearly on X-ray screens during the operation.
Will I know which dye I'm getting?
No, you won't know, nor will your doctors. This is called 'blinding' and helps make the study results fair.
How long will I be involved in the study?
You'll be monitored after surgery and have follow-up appointments for up to 3 years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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