Peripheral Arterial Disease(PAD)CLARITYNCT06979284
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
A study testing IVUS-guided strategy in people with Peripheral Arterial Disease(PAD) and Chronic Limb Threatening Ischemia, run by Hamilton Health Sciences Corporation at 5 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia, Intravascular Ultrasound
- What is being tested?
- IVUS-guided strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 5 sitesCanada
- Study dates
- 5 Dec 2025to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with lower extremity PAD manifesting as CLTI:
- 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
- Scheduled to undergo percutaneous revascularization, AND
- Informed consent
- 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 that is responsible for CLTI of the index limb
- An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of > 2.5mm by investigator 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).
Who cannot join
- The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements.
- The presence of any medical conditions precluding percutaneous revascularization
- The subject has previously had or requires open 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
Show all 18Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Hamilton General Hospital
Hamilton
Project Manager, 905-521-2100, clarity@phri.ca
John Harlock, MD MSc FRCSC FACS
- Recruiting
Centre Hospitalier De L'Universite De Montreal (CHUM)
Montreal, Quebec
Project Manager, 905-521-2100, clarity@phri.ca
Laura Drudi, MDCM, MSc, FRCSC, FACS, FAHA
- Recruiting
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec
Project Manager, 905-521-2100, clarity@phri.ca
Elie Girsowicz, MD, MSc
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
Project Manager, 905-521-2100, clarity@phri.ca
Marc-André d'Entremont, MD, MPH, PhD, FRCPC, DRCPSC
- Recruiting
Unity Health Toronto - St. Micheal's Hospital
Toronto
Project Manager, 905-521-2100, clarity@phri.ca
Graham McClure, MD, MSc, FRCSC, PhDc
About this study
Official title: Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled 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.
- Conditions
- Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia, Intravascular Ultrasound, Major Adverse Limb Events, Restenosis
- Being tested
- IVUS-guided strategy
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided strategyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravascular Ultrasound - guided strategy | Active comparator | Percutaneous revascularization will be performed using intravascular ultrasound. Receives: Procedure: IVUS-guided strategy |
| Angiography - guided strategy | No intervention | A standard-of-care percutaneous revascularization will be performed without using intravascular ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (10)
The composite of all-cause mortality, MALE, or target-lesion binary restenosis
Measured: From date of randomization until the date of death, MALE, or target lesion binary restenosis, assessed up to a maximum of 5 years.
MALE
Measured: From date of randomization, assessed up to a maximum of 5 years.
All-cause mortality
Measured: From date of randomization, assessed up to a maximum of 5 years.
Unplanned above-ankle amputation of the index limb
Measured: From date of randomization, assessed up to a maximum of 5 years.
Clinically-driven target lesion revascularization
Measured: From date of randomization, assessed up to a maximum of 5 years.
Target lesion binary restenosis
Measured: From date of randomization, assessed up to a maximum of 5 years.
Unplanned minor amputation of the index limb
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of randomization, assessed up to a maximum of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start5 Dec 2025
- Primary completionJul 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, international, prospective, randomized, open, blinded endpoint (PROBE) parallel trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979284
- Sponsor's protocol ID
- 5251
- Acronym
- CLARITY
- Status last verified
- Jun 2026
- First submitted
- 2 May 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06979284
- Acronym / sponsor ID
- CLARITY / 5251
- Conditions
- Peripheral Arterial Disease(PAD), Chronic Limb Threatening Ischemia, Intravascular Ultrasound, Major Adverse Limb Events, Restenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, international, prospective, randomized, open, blinded endpoint (PROBE) parallel trial.
| Arm | Type | Receives |
|---|---|---|
| Intravascular Ultrasound - guided strategy | Active comparator | Procedure: IVUS-guided strategyPercutaneous revascularization will be performed using intravascular ultrasound. |
| Angiography - guided strategy | No intervention | –A standard-of-care percutaneous revascularization will be performed without using intravascular ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients presenting with lower extremity PAD manifesting as CLTI:
- Scheduled to undergo percutaneous revascularization, AND
- Informed consent
- 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 that is responsible for CLTI of the index limb
- An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of > 2.5mm by investigator visual assessment.
Key exclusion criteria (18 listed)
- The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements.
- The presence of any medical conditions precluding percutaneous revascularization
- The subject has previously had or requires open 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS-guided strategyPercutaneous 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. | Procedure or surgery | Intravascular Ultrasound - guided strategy |
Primary outcome
Time-to-first occurrence of MALE
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.
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.
10 secondary outcomes
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
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
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
Time frame: From date of randomization, assessed up to a maximum of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-guided strategy in people with Peripheral Arterial Disease(PAD) and Chronic Limb Threatening Ischemia, run by Hamilton Health Sciences Corporation at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CLARITY Project Office (905-521-2100, CLARITY@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-first occurrence of MALE (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.