Intravascular Ultrasound for Peripheral Artery Disease

(CLARITY Trial)

This trial aims to determine whether using intravascular ultrasound (IVUS) during artery procedures can better prevent major limb issues or artery re-narrowing compared to standard imaging techniques alone. It targets individuals with chronic limb-threatening ischemia (CLTI), which may present as constant foot pain, non-healing wounds, or gangrene due to poor blood flow. Candidates must be scheduled for a procedure to open blocked leg arteries and have imaging confirming significant artery blockage. As an unphased trial, this study provides an opportunity to contribute to medical advancements that could enhance treatment options for CLTI.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that using intravascular ultrasound (IVUS) during treatments for peripheral artery disease (PAD) is generally safe. Studies have found that IVUS can lower the risk of major amputations and improve treatment success. For example, one study found that patients with IVUS-guided treatments had fewer amputations within a year compared to those with angiography-guided treatments. Another study demonstrated that IVUS led to better outcomes, such as higher success rates, than angiography alone.

Researchers are excited about using intravascular ultrasound (IVUS) for treating peripheral artery disease because it offers a more precise way to guide revascularization procedures. Unlike the standard approach that relies solely on angiography, IVUS provides detailed images from inside the blood vessels, allowing for better assessment of plaque and vessel walls. This enhanced imaging could lead to more accurate treatment, potentially improving outcomes and reducing complications for patients.

This trial will compare an intravascular ultrasound (IVUS)-guided strategy with an angiography-guided strategy for treating peripheral artery disease (PAD). Studies have shown that IVUS can lead to better outcomes for patients with PAD. Specifically, procedures guided by IVUS help keep arteries open longer, with 83.8% of patients maintaining good blood flow after one year. IVUS is also linked to fewer major amputations compared to traditional imaging methods. It allows doctors to see inside blood vessels more clearly, enabling more precise treatment. Additionally, IVUS has been associated with higher success rates during procedures, with 76.5% achieving technical success compared to 61% with angiography alone. Overall, evidence supports IVUS as a promising tool for improving treatment results in PAD.¹²³⁴⁶