Health TrialsbyHealthPanel

Intravascular Ultrasound for Peripheral Artery Disease Revascularization

ConditionsPeripheral Arterial Disease(PAD)Chronic Limb Threatening IschemiaIntravascular UltrasoundMajor Adverse Limb EventsRestenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • IVUS-guided strategy

    Procedure/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.

Treatment groups

772 Participants
are divided into 2 treatment groups
Group A: Intravascular Ultrasound - guided strategyActive comparator 1 intervention
Group B: Angiography - guided strategyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

MALE

Time frame
From date of randomization, assessed up to a maximum of 5 years.
3

All-cause mortality

Time frame
From date of randomization, assessed up to a maximum of 5 years.
4

Unplanned above-ankle amputation of the index limb

Time frame
From date of randomization, assessed up to a maximum of 5 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

Source ClinicalTrials.gov
Apply now