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Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

ConditionsPeripheral Arterial DiseaseLower Extremity Arterial Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Research Institute

About this trial

This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Symptomatic LE PAD - Rutherford Class 2-5

Angiographic evidence of >50% stenosis

Undergoing LE peripheral artery intervention

Disqualifiers

Prior intervention at the target lesion within 6 months

Target lesion is abdominal aorta or inframalleolar BTK arteries

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravascular Ultrasound (IVUS)

    Device

    pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement

  • Angiographic-guided Intervention

    Device

    Standard angiography-guided intervention without IVUS.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Intravascular Ultrasound (IVUS)Active comparator 1 intervention
Group B: Non-Intravascular Ultrasound (IVUS)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary Patency

Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR).

Time frame
From enrollment to 6 months

Secondary outcomes

1

Technical Success

Technical success is defined as less than 30% residual stenosis in the target lesion following the index procedure. Residual stenosis determined by operator visual estimation.

Time frame
Collected from index procedure
2

Procedural Success

Procedural success is technical success (less than 30 % residual stenosis in the target lesion) without the occurrence of procedural complications during the index procedure. Residual stenosis determined by operator visual estimation.

Time frame
Collected from Index procedure
3

Clinically driven-TLR (CD-TLR)

Clinically driven-target limb revascularization. Information collected from the medical record.

Time frame
From enrollment to 12 months
4

Amputation-free Survival

Defined as no evidence of amputation. Information is collected from the medical record

Time frame
From enrollment to 12 months

Other outcomes

Sponsors and contacts

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

Baylor Research Institute

Lead sponsor

Philips Healthcare

Collaborator

Source ClinicalTrials.gov
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