An interventional study of IVUS-guided strategy in Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia and Intravascular Ultrasound, sponsored by Hamilton Health Sciences Corporation. Recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Prevention
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.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 772 is above the median of 40 across 239 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
Compared within Chronic Limb-Threatening Ischemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients presenting with lower extremity PAD manifesting as CLTI:
a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene present for at least two weeks and that is attributable to objectively proven arterial occlusive disease, compatible with Rutherford class 4, 5 or 6 AND
Exclusion Criteria:
Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percutaneous revascularization will be performed using intravascular ultrasound.
Procedure: IVUS-guided strategy
A standard-of-care percutaneous revascularization will be performed without using intravascular ultrasound.
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.
Wound healing status of the index limb based on the Wound, Ischemia, Foot Infection (WIFI) scale at 12 months
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 1 year
Change in the Walking Impairment Questionnaire (WIQ) score at 12 months
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 1 year
Change in the Vascular Quality of Life Questionnaire-6 (VascQol-6) score at 12 months
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 1 year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chronic Limb-Threatening Ischemia →
Hamilton Health Sciences Corporation →