RecruitingNAINTERVENTIONAL

Intravascular Ultrasound for Peripheral Artery Disease Revascularization

This study aims to discover if a special ultrasound, called intravascular ultrasound (IVUS), can improve outcomes for people with advanced Peripheral Arterial Disease (PAD). PAD causes narrowed arteries, often in the legs, leading to pain and wounds. During a procedure to unblock these arteries, doctors usually rely on X-ray imaging. This study will compare standard X-ray imaging with a method that also uses IVUS. Researchers want to see if using IVUS helps prevent serious leg problems in the future, such as new blockages or needing further treatment. This research could help doctors understand the best ways to treat severe PAD.

At a glance

Status

Recruiting

Phase

Sponsor

Hamilton Health Sciences Corporation

Enrolment target

772

Start

05 Dec 2025

Estimated completion

01 Oct 2030

Peripheral Arterial Disease(PAD)Chronic Limb Threatening Ischemia Intravascular Ultrasound Major Adverse Limb Events Restenosis

What is this study about?

Peripheral Arterial Disease (PAD) is a common condition where narrowing of the arteries, most commonly in the legs, reduces blood flow. This can cause leg pain, especially during exercise, and if severe, can lead to chronic limb-threatening ischemia (CLTI). CLTI means there isn't enough blood getting to the leg and foot, which can cause severe pain even at rest, non-healing wounds, or even gangrene.

When someone has CLTI, doctors often perform a procedure called percutaneous revascularization. This is a keyhole procedure to open up the blocked or narrowed arteries in the leg, helping to restore blood flow. During this procedure, doctors typically use X-ray images (angiography) to guide them.

This study is investigating whether using an additional tool, called intravascular ultrasound (IVUS), alongside the standard X-ray guidance, can lead to better long-term results. IVUS involves inserting a tiny ultrasound probe into the artery itself to get a very detailed view from the inside. The researchers want to find out if using IVUS helps prevent two main problems: serious complications affecting the limb, and the treated artery narrowing again (called restenosis) by more than 50%. The results of this study could help doctors decide if IVUS should become a standard part of treating severe PAD.

Key takeaways

This study investigates a new way to guide leg artery procedures.
It compares standard X-ray imaging with additional internal ultrasound (IVUS).
The goal is to prevent future blockages and serious leg complications in severe PAD.
Participation involves your scheduled procedure and follow-up checks.
It's for adults with severe leg circulation problems (CLTI).

Who may be eligible?

To be part of this study, you would need to be an adult (18 or older) with a severe form of Peripheral Arterial Disease (PAD) in your legs. This means you would be experiencing symptoms like rest pain in your leg, wounds that aren't healing, or gangrene due to poor blood flow. Doctors will have already confirmed your PAD with tests showing significantly reduced blood pressure in your ankle or toes.

Also, you must be scheduled to have a keyhole procedure (percutaneous revascularization) to open up the blocked arteries in your leg. Imaging tests would need to show a significant blockage (more than 70%) in certain leg arteries, and the vessel targeted for treatment needs to be of a certain size and location for the study.

There are also reasons why you might not be able to join. For example, if you have other medical problems that would make joining difficult or unsafe, or if you've recently had or need open surgery on the same artery being studied. The study team will review all your medical information to see if this study is suitable for you.

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 an adult (18 or older)?
Do you have severe leg PAD with rest pain, non-healing wounds, or gangrene?
Are you scheduled for a keyhole procedure to open arteries in your leg?
Do you have a significant blockage in one of your lower leg arteries?
Have you been told you don't have other conditions that would make participation risky?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will be during your scheduled keyhole procedure to unblock your leg arteries. In addition to the usual X-ray guidance, you may also have the intravascular ultrasound (IVUS) used during this procedure. After the procedure, you will have follow-up appointments where doctors will check on your healing and blood flow. These appointments will involve blood tests, physical examinations, and possibly imaging scans (like ultrasound) to see how your treated artery is doing. The exact number and timing of visits, and the total duration of your participation, will be explained to you by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that if the IVUS-guided approach proves more effective, it could lead to better outcomes for your leg, such as a lower chance of future blockages or serious leg problems. However, there's no guarantee of direct personal benefit from participating. Potential risks involved are generally those associated with the standard percutaneous revascularization procedure itself, such as bleeding, infection, or damage to blood vessels. There's also a small additional risk from using the IVUS device, but it is generally considered safe. You will be fully informed of all potential risks before you consent. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Hamilton General Hospital
Verified postcode
Hamilton, Canada· Recruiting
Unity Health Toronto - St. Micheal's Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where arteries in your legs become narrowed, reducing blood flow and causing pain or sores.

What is 'chronic limb-threatening ischemia' (CLTI)?

CLTI is the most severe form of PAD, where lack of blood flow can cause constant pain, non-healing wounds, or gangrene in the limb.

What is 'intravascular ultrasound' (IVUS) guided treatment?

IVUS is a special ultrasound used inside your artery during surgery to help doctors see blockages very clearly, in addition to standard X-ray guidance.

What does 'revascularization' mean?

Revascularization is a procedure (often keyhole) to open up blocked arteries and improve blood flow, often to the legs.

What is 'restenosis'?

Restenosis means that an artery that has been treated for a blockage starts to narrow again over time.

How to find out more

CLARITY Project Office

clarity@phri.ca 905-521-2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.