ongoing

Given the current rates of amputation and death in chronic limb threatning ischemia, improving outcomes after infrainguinal percutaneous revascularization would have a tremendous public health impact. Translating emerging intravascular imaging evidence from coronary disease to high-risk peripheral arterial disease patients should be prioritized.

Therefore, the aim of the CLARITY Vanguard Phase is determine the feasibility of conducting a large, multicenter randomized controlled trial to examine whether an intravascular ultrasound (IVUS)-guided strategy is effective and safe to prevent major adverse limb events (MALE), defined as above-ankle amputation or clinically driven target lesion revascularization, or target lesion binary restenosis, defined as > 50% stenosis, in patients with chronic limb-threatening ischemia undergoing percutaneous revascularization.  

Study Type

Intervention - Procedure

Study Design

Randomized controlled trial

NO. of Countries

2

NO. of Sites

5

NO. of Participants

100 (vanguard)

Study Period

2025-2027

Sponsor

PHRI

The CLARITY study team at Hamilton General Hospital, including principal investigators Marc-André d’Entremont and Sanjit Jolly, after enrolling the first patient on December 19, 2025.

Canadian Institutes of Health Research

Hamilton Academic Health Sciences Organization

Heart and Stroke Foundation of Canada

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