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New treatment option for Peripheral Arterial Disease(PAD)
Official title Intravascular Ultrasound for Peripheral Artery Disease Revascularization
ClinicalTrials.gov ID: NCT06979284
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients presenting with lower extremity PAD manifesting as CLTI: a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene...
- 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...
- An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of \> 2.5mm by investigator...
You likely can't join if
- The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Canada
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Canada; Toronto, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.