Intravascular Ultrasound For Peripheral Artery Disease Revascularization The CLARITY Randomized Controlled Trial
About the role
Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06979284
Intravascular Ultrasound for Peripheral Artery Disease Revascularization The CLARITY Randomized Controlled Trial
Led by Hamilton Health Sciences Corporation
Updated on 2026-06-08
772
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
AI-Summary
What This Trial Is About
Researchers are evaluating whether using intravascular ultrasound IVUS during percutaneous revascularization can better prevent major adverse limb events MALE or significant artery narrowing restenosis compared to using angiography alone in adults with chronic limb threatening ischemia CLTI caused by peripheral arterial disease PAD. The study aims to understand if IVUS guidance improves outcomes after artery treatment in this population. Participants will be randomly assigned to one of two groups one receiving percutaneous revascularization guided by IVUS, where operators use ultrasound to optimize treatment of arteries hardened by calcium, and the other receiving standard care guided by angiography alone without IVUS. The procedures focus on unblocking arteries affected by PAD and CLTI. The study will follow participants for up to 5 years after treatment. Throughout the study, researchers will monitor participants regularly to track the time until the first major adverse limb event, including unplanned above-ankle amputations, need for additional artery treatment, or restenosis. They will also assess mortality, wound healing using the WIFI scale, walking ability, and vascular quality of life. Data will be collected up to five years post-randomization to evaluate long-term safety and effectiveness of the treatment strategies.
CONDITIONS
Brief Title
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Patients with lower extremity peripheral arterial disease showing chronic limb threatening ischemia (CLTI) defined by rest foot pain, nonhealing wounds, or gangrene lasting at least two weeks, meeting specific pressure and pulse volume criteria Scheduled to undergo percutaneous revascularization Provided informed consent Imaging evidence of an obstructive or occluded lesion (>70%) in the infrainguinal circulation Infrapopliteal lesions located in the proximal two-thirds of native vessels with diameter >2.5 mm Distal margin of the most distal target lesion located >10 cm proximal to the ankle, with patent vessel segment distal to lesion
You will not qualify if you...
Anatomic, medical, social, or psychological conditions limiting ability to participate or comply with follow-up Medical conditions preventing percutaneous revascularization Previous or planned surgical revascularization of the target vessel in the same leg Bedridden or unable to walk (assistance allowed) Life expectancy less than 12 months Age under 18 years Active vasculitis, Buerger's disease, or acute limb-threatening ischemia Planned above-ankle amputation within four weeks of the procedure Untreated obstructive supra-inguinal inflow (>70% stenosis) not planned for treatment Prior amputations to the ipsilateral leg other than toe/forefoot, or major contralateral amputation within one year with inability to walk independently Extensive tissue loss requiring complex foot reconstruction or non-traditional amputations, including osteomyelitis beyond metatarsal heads, gangrene involving plantar skin, large plantar ulcers (>3 cm), full-thickness heel ulcers, wounds with calcaneal bone involvement, wounds needing flap coverage or complex management, and full-thickness dorsal foot wounds exposing tendon or bone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
First name *
Last name *
Email Address *
Phone Number *
+1
Gender*
ZIP Code *
I agree to receive SMS messages from DecenTrialz regarding trial matching, appointment updates, participant updates, and related information. Message frequency varies. Message & data rates may apply. Reply STOP to cancel or HELP for assistance. I also agree to the Terms of Service and Privacy Policy.*
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with immediate recovery
Participants undergo percutaneous revascularization either guided by intravascular ultrasound or by angiography as part of the standard care to unblock arteries affected by peripheral artery disease.
1 procedure visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor outcomes such as limb events, wound healing, quality of life, and survival after the revascularization procedure.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Hamilton General Hospital
Hamilton, Canada
Actively Recruiting
2
Unity Health Toronto - St. Micheal's Hospital
Toronto, Canada
Actively Recruiting
+−
Leaflet
Research Team
C
CLARITY Project Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Multicenter Registry for Paclitaxel-Coated Balloon Angioplas...
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1 location
Optimal Strategy to Correct Stent Underexpansion in Resistan...
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Actively Recruiting
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Actively Recruiting
2 locations
Revascularization of Single Versus Multiple Infrapopliteal V...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Real-World Clinical Evaluation of the Shockwave Intravascula...
Peripheral Artery Disease (PAD)
Actively Recruiting
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Assessment of Revascularization in Plantar Foot of Diabetic ...
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Actively Recruiting
1 location
Multicenter Registry for Paclitaxel-Coated Balloon Angioplas...
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Actively Recruiting
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Evaluation of Lower Limb Angiosome Perfusion and Oxygenation...
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Actively Recruiting
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2 locations
Revascularization of Single Versus Multiple Infrapopliteal V...
Chronic Limb Threatening Ischemia
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1 location
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
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On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
Not the right fit? Search for Intravascular Ultrasound For Peripheral Artery Disease Revascularization The CLARITY Randomized Controlled Trial jobs in Hamilton, Ontario, Canada
About DecenTrialz
DecenTrialz is the trusted digital partner for the clinical research ecosystem, dedicated to accelerating medical innovation by fundamentally democratizing access to clinical trials. Our unified platform is engineered to dismantle the systemic geographical, socioeconomic, and informational barriers that have long hindered participation, seamlessly connecting sponsors, CROs, and sites with a more diverse and engaged population of participants. Grounded in an unwavering commitment to trust, ethical principles, and regulatory compliance, we empower researchers with the intelligent tools needed for efficient recruitment while providing patients with a clear, secure, and accessible pathway to participation. Ultimately, our work forges a more inclusive and effective research landscape, speeding the delivery of life-changing therapies to humanity.
Vision:
We envision a world where clinical research is a shared global effort, not limited by geography, income, or background. In this future, every community has a seat at the table of discovery, and trials reflect the true diversity of humanity. By broadening access and accelerating participation, we aim to transform how quickly innovation turns into care, creating a healthier future that belongs to everyone.
Goals:
Our Goal is to democratize clinical research by opening participation to people everywhere and ensuring diverse voices are represented in discovery. We work to remove barriers that slow progress, so research can move faster and bring new treatments to patients who need them. By making trials more inclusive and representative, we aim to strengthen trust in science and ensure that Medical breakthroughs serve humanity as a whole.
Similar Jobs
Intravascular Ultrasound For Peripheral Artery Disease Revascularization The CLARITY Randomized Controlled Trial
About the role
Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06979284
Intravascular Ultrasound for Peripheral Artery Disease Revascularization The CLARITY Randomized Controlled Trial
Led by Hamilton Health Sciences Corporation
Updated on 2026-06-08
772
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
AI-Summary
What This Trial Is About
Researchers are evaluating whether using intravascular ultrasound IVUS during percutaneous revascularization can better prevent major adverse limb events MALE or significant artery narrowing restenosis compared to using angiography alone in adults with chronic limb threatening ischemia CLTI caused by peripheral arterial disease PAD. The study aims to understand if IVUS guidance improves outcomes after artery treatment in this population. Participants will be randomly assigned to one of two groups one receiving percutaneous revascularization guided by IVUS, where operators use ultrasound to optimize treatment of arteries hardened by calcium, and the other receiving standard care guided by angiography alone without IVUS. The procedures focus on unblocking arteries affected by PAD and CLTI. The study will follow participants for up to 5 years after treatment. Throughout the study, researchers will monitor participants regularly to track the time until the first major adverse limb event, including unplanned above-ankle amputations, need for additional artery treatment, or restenosis. They will also assess mortality, wound healing using the WIFI scale, walking ability, and vascular quality of life. Data will be collected up to five years post-randomization to evaluate long-term safety and effectiveness of the treatment strategies.
CONDITIONS
Brief Title
Intravascular Ultrasound for Peripheral Artery Disease Revascularization
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Patients with lower extremity peripheral arterial disease showing chronic limb threatening ischemia (CLTI) defined by rest foot pain, nonhealing wounds, or gangrene lasting at least two weeks, meeting specific pressure and pulse volume criteria Scheduled to undergo percutaneous revascularization Provided informed consent Imaging evidence of an obstructive or occluded lesion (>70%) in the infrainguinal circulation Infrapopliteal lesions located in the proximal two-thirds of native vessels with diameter >2.5 mm Distal margin of the most distal target lesion located >10 cm proximal to the ankle, with patent vessel segment distal to lesion
You will not qualify if you...
Anatomic, medical, social, or psychological conditions limiting ability to participate or comply with follow-up Medical conditions preventing percutaneous revascularization Previous or planned surgical revascularization of the target vessel in the same leg Bedridden or unable to walk (assistance allowed) Life expectancy less than 12 months Age under 18 years Active vasculitis, Buerger's disease, or acute limb-threatening ischemia Planned above-ankle amputation within four weeks of the procedure Untreated obstructive supra-inguinal inflow (>70% stenosis) not planned for treatment Prior amputations to the ipsilateral leg other than toe/forefoot, or major contralateral amputation within one year with inability to walk independently Extensive tissue loss requiring complex foot reconstruction or non-traditional amputations, including osteomyelitis beyond metatarsal heads, gangrene involving plantar skin, large plantar ulcers (>3 cm), full-thickness heel ulcers, wounds with calcaneal bone involvement, wounds needing flap coverage or complex management, and full-thickness dorsal foot wounds exposing tendon or bone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
First name *
Last name *
Email Address *
Phone Number *
+1
Gender*
ZIP Code *
I agree to receive SMS messages from DecenTrialz regarding trial matching, appointment updates, participant updates, and related information. Message frequency varies. Message & data rates may apply. Reply STOP to cancel or HELP for assistance. I also agree to the Terms of Service and Privacy Policy.*
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with immediate recovery
Participants undergo percutaneous revascularization either guided by intravascular ultrasound or by angiography as part of the standard care to unblock arteries affected by peripheral artery disease.
1 procedure visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are followed for up to 5 years to monitor outcomes such as limb events, wound healing, quality of life, and survival after the revascularization procedure.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Hamilton General Hospital
Hamilton, Canada
Actively Recruiting
2
Unity Health Toronto - St. Micheal's Hospital
Toronto, Canada
Actively Recruiting
+−
Leaflet
Research Team
C
CLARITY Project Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Real-World Clinical Evaluation of the Shockwave Intravascula...
Peripheral Artery Disease (PAD)
Actively Recruiting
1 location
Assessment of Revascularization in Plantar Foot of Diabetic ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
1 location
Multicenter Registry for Paclitaxel-Coated Balloon Angioplas...
Arteriosclerosis
Actively Recruiting
10 locations
Intravascular Ultrasound for Peripheral Artery Disease Revas...
Peripheral Arterial Disease(PAD)
Actively Recruiting
2 locations
Korean Vascular Intervention Society Multicenter Registry St...
Peripheral Arterial Disease(PAD)
Actively Recruiting
1 location
Evaluation of Lower Limb Angiosome Perfusion and Oxygenation...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Optimal Strategy to Correct Stent Underexpansion in Resistan...
Coronary Angioplasty
Actively Recruiting
2 locations
Prospective, Multicenter, Single-Arm Observational Study to ...
Peripheral Arterial Disease
Actively Recruiting
16 locations
A Prospective, Multicenter, Single Arm, Real-World Registry ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
2 locations
Revascularization of Single Versus Multiple Infrapopliteal V...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
A Prospective, Multicenter, Single Arm, Real-World Registry ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
2 locations
Revascularization of Single Versus Multiple Infrapopliteal V...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Real-World Clinical Evaluation of the Shockwave Intravascula...
Peripheral Artery Disease (PAD)
Actively Recruiting
1 location
Assessment of Revascularization in Plantar Foot of Diabetic ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
1 location
Multicenter Registry for Paclitaxel-Coated Balloon Angioplas...
Arteriosclerosis
Actively Recruiting
10 locations
Korean Vascular Intervention Society Multicenter Registry St...
Peripheral Arterial Disease(PAD)
Actively Recruiting
1 location
Evaluation of Lower Limb Angiosome Perfusion and Oxygenation...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Optimal Strategy to Correct Stent Underexpansion in Resistan...
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A Prospective, Multicenter, Single Arm, Real-World Registry ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
2 locations
Revascularization of Single Versus Multiple Infrapopliteal V...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Real-World Clinical Evaluation of the Shockwave Intravascula...
Peripheral Artery Disease (PAD)
Actively Recruiting
1 location
Assessment of Revascularization in Plantar Foot of Diabetic ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
1 location
Multicenter Registry for Paclitaxel-Coated Balloon Angioplas...
Arteriosclerosis
Actively Recruiting
10 locations
Korean Vascular Intervention Society Multicenter Registry St...
Peripheral Arterial Disease(PAD)
Actively Recruiting
1 location
Evaluation of Lower Limb Angiosome Perfusion and Oxygenation...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Optimal Strategy to Correct Stent Underexpansion in Resistan...
Coronary Angioplasty
Actively Recruiting
2 locations
Prospective, Multicenter, Single-Arm Observational Study to ...
Peripheral Arterial Disease
Actively Recruiting
16 locations
A Prospective, Multicenter, Single Arm, Real-World Registry ...
Peripheral Arterial Disease(PAD)
Actively Recruiting
2 locations
Revascularization of Single Versus Multiple Infrapopliteal V...
Chronic Limb Threatening Ischemia
Actively Recruiting
1 location
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
Not the right fit? Search for Intravascular Ultrasound For Peripheral Artery Disease Revascularization The CLARITY Randomized Controlled Trial jobs in Hamilton, Ontario, Canada
About DecenTrialz
DecenTrialz is the trusted digital partner for the clinical research ecosystem, dedicated to accelerating medical innovation by fundamentally democratizing access to clinical trials. Our unified platform is engineered to dismantle the systemic geographical, socioeconomic, and informational barriers that have long hindered participation, seamlessly connecting sponsors, CROs, and sites with a more diverse and engaged population of participants. Grounded in an unwavering commitment to trust, ethical principles, and regulatory compliance, we empower researchers with the intelligent tools needed for efficient recruitment while providing patients with a clear, secure, and accessible pathway to participation. Ultimately, our work forges a more inclusive and effective research landscape, speeding the delivery of life-changing therapies to humanity.
Vision:
We envision a world where clinical research is a shared global effort, not limited by geography, income, or background. In this future, every community has a seat at the table of discovery, and trials reflect the true diversity of humanity. By broadening access and accelerating participation, we aim to transform how quickly innovation turns into care, creating a healthier future that belongs to everyone.
Goals:
Our Goal is to democratize clinical research by opening participation to people everywhere and ensuring diverse voices are represented in discovery. We work to remove barriers that slow progress, so research can move faster and bring new treatments to patients who need them. By making trials more inclusive and representative, we aim to strengthen trust in science and ensure that Medical breakthroughs serve humanity as a whole.