Testing IVUS-guided strategy for peripheral arterial disease(PAD)
Official title: Intravascular Ultrasound for Peripheral Artery Disease Revascularization
Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled Trial
- 2 groups
- Sites in Hamilton and Toronto
- Recruiting
Interventions
- Medical procedure
IVUS-guided strategy
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.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Hamilton General Hospital
Hamilton
- Recruiting
Unity Health Toronto - St. Micheal's Hospital
Toronto
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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, with the following supporting hemodynamic criteria1: i. For ischemic rest pain (Rutherford category 4): Ankle systolic pressure \< 40mmHg, toe pressure \< 30mmHg, or flat-line transtarsal pulse volume recording, OR ii. For tissue loss (Rutherford category 5, 6): Ankle systolic pressure \< 60 mmHg, toe pressure of \< 40mmHg, or flat-line transtarsal volume recording, AND
- +Scheduled to undergo percutaneous revascularization, AND
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Imaging evidence of an obstructive or occluded lesion (\> 70%) in the infraiguinal circulation (e.g. femoral, popliteal, or infrapopliteal circulation) using angiography, ultrasound, computed tomography, or magnetic resonance imaging.
- +An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of \> 2.5mm by investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → visual assessment.
- +The distal margin of the most distal target lesion must be located \> 10 cm proximal to the proximal margin on the ankle mortise. The vessel segment distal to the most distal target lesion must be patent all the way to the ankle, with no obstructive lesion (\>50% stenosis).
Exclusion
- −The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → requirements.
- −The presence of any medical conditions precluding percutaneous revascularization
- −The subject has previously had or requires surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.
- −The subject is bedridden or unable to walk (with assistance is acceptable).
- −Life expectancy \< 12 months
- −Age \< 18 years
- −Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- −Planned above-ankle amputation of the index limb within four weeks of the index procedure.
- −Obstructive supra-inguinal "inflow" (\>70% stenosis) which is not planned to be treated during index procedure or within 30 days of the index procedure.
- −The subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or the subject has had a major amputation to the contralateral extremity \< 1 year before the index procedure and is not independently walking.
- −Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations.
- −Osteomyelitis that extends proximal to the metatarsal heads
- −Gangrene involving the plantar skin of the forefoot, midfoot or heel
- −Deep ulcer or large shallow ulcer (\> 3 cm) involving the plantar skin of the f forefoot, midfoot, or heel
- −Full-thickness heel ulcer
- −Any wound with calcaneal bone involvement
- −Wounds that would require flap coverage or complex wound management for large soft tissue defect
- −Full-thickness wounds on the dorsum of the foot with exposed tendon or bone.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives IVUS-guided strategy.
Registry label: A: Intravascular Ultrasound - guided strategy
Group B receives no study treatment and is followed for comparison.
Registry label: B: Angiography - guided strategy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 772 people.
The study is currently expected to finish around October 2030.
The main measurement is taken over: From date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time-to-first occurrence of MALE — measured over From date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06979284 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About IVUS-guided strategyProcedure
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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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 study as a whole is currently expected to finish around 2030-10.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 772 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Hamilton, Canada; Toronto, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.