Comparing Two Types of Balloon Treatment for Poor Leg Circulation
For people with: Peripheral Arterial Disease
About this trial
This trial is for people with very poor blood flow in their legs, which can cause pain and difficulty walking. We are comparing two types of balloon treatment to open up narrowed blood vessels — one uses a special drug coating and the other does not. We want to see which keeps the blood vessel open for longer.
What would I need to do?
You will have a procedure where a small balloon is passed into the narrowed blood vessel in your leg to widen it. You will be randomly chosen to have either a drug-coated balloon or a standard balloon. You will attend follow-up appointments at 1, 6, 12 and 24 months so we can check the blood flow in your leg.
You will come to the hospital on the day of your procedure. After that, you will have check-up visits at 1 month, 6 months, 12 months and 24 months. At each visit, you will have an ultrasound scan of your leg and the team will check your symptoms and any wounds.
Could I take part?
You may be eligible if you have been diagnosed with severe narrowing of the arteries in your leg that is causing rest pain, ulcers, or difficulty walking short distances. Your vascular team will check whether this trial is suitable for you.
Age range: 40 years and over
What are the risks and benefits?
The balloon procedure is a well-established treatment. Possible risks include bruising at the puncture site, bleeding, infection, and (rarely) damage to the blood vessel. The drug-coated balloon may keep the vessel open for longer, but there is ongoing research into its long-term safety. By taking part, you will receive close monitoring and help answer an important question for future patients.
Common questions
Interested in taking part?
Contact the research team to find out more about this trial and whether it might be right for you.
Latest News & Updates
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