The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
772
Percutaneous revascularization will be performed using intravascular ultrasound. The operators will follow instructions to modify arteries hardened by calcium and use IVUS to optimize the equipment (balloon and stents) used to unblock the artery.
Time-to-first occurrence of MALE
Defined as unplanned above ankle amputation of the index limb or clinically driven target lesion revascularization, or target-lesion binary restenosis, defined as \> 50% stenosis on imaging throughout follow-up.
Time frame: From date of randomization until the date of first unplanned above ankle amputation of the index limb, clinically driven target lesion revascularization or target-lesion binary restenosis, assessed up to a maximum of 5 years.
The composite of all-cause mortality, MALE, or target-lesion binary restenosis
Time frame: From date of randomization until the date of death, MALE, or target lesion binary restenosis, assessed up to a maximum of 5 years.
MALE
Time frame: From date of randomization, assessed up to a maximum of 5 years.
All-cause mortality
Time frame: From date of randomization, assessed up to a maximum of 5 years.
Unplanned above-ankle amputation of the index limb
Time frame: From date of randomization, assessed up to a maximum of 5 years.
Clinically-driven target lesion revascularization
Time frame: From date of randomization, assessed up to a maximum of 5 years.
Target lesion binary restenosis
Time frame: From date of randomization, assessed up to a maximum of 5 years.
Unplanned minor amputation of the index limb
Time frame: From date of randomization, assessed up to a maximum of 5 years.
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Wound healing status of the index limb based on the Wound, Ischemia, Foot Infection (WIFI) scale throughout follow-up
The WIFI assessment refers to the Wound, Ischemia, and Foot Infection (WIFI) classification system. This system is used to standardize the measurement of wound healing, particularly in patients with peripheral artery disease (PAD). It is not a questionnaire but rather a classification method that helps in assessing the severity of wounds, the degree of ischemia (restricted blood supply), and the presence of foot infections. Wound, Ischemia and foot infection are all graded on a scale of 0-3, with higher grades indicating more severe conditions.
Time frame: From date of randomization, assessed up to a maximum of 5 years.
Change in the Walking Impairment Questionnaire (WIQ) score throughout follow-up
The Walking Impairment Questionnaire (WIQ) is a tool designed to measure walking ability in patients with Peripheral Arterial Disease (PAD). It assesses the impact of PAD on walking distance, walking speed, and the ability to climb stairs. The WIQ is particularly useful for evaluating the severity of walking impairment and the effectiveness of interventions aimed at improving walking ability in these patients. The WIQ includes several categories, each scored on a scale from 0 to 100, with higher scores indicating better walking ability. Each category score is calculated based on the patient's self-reported ability to perform these activities. The scores are then used to provide an overall assessment of the patient's walking impairment.
Time frame: From date of randomization, assessed up to a maximum of 5 years.
Change in the Vascular Quality of Life Questionnaire-6 (VascQol-6) score throughout follow-up
The VascuQoL-6 questionnaire is a health-related quality of life (QoL) assessment tool specifically designed for patients with peripheral arterial disease (PAD). It is used in clinical practice and vascular registries to evaluate the impact of PAD on patients' quality of life. Scale Determination The VasQol-6 consists of six questions, each scored on a scale from 1 to 4. The scores for each question are summed to generate a total Quality of Life score. A higher total score indicates a better health status. Score 1: Indicates the worst health status. Score 4: Indicates the best health status.
Time frame: From date of randomization, assessed up to a maximum of 5 years.