Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries

Baylor Research Institute350 enrolled

Overview

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.

This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Lower Extremity (LE) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

350

Conditions

Peripheral Arterial Disease Lower Extremity Arterial Disease

Interventions

Intravascular Ultrasound (IVUS)DEVICE

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

Angiographic-guided InterventionDEVICE

Standard angiography-guided intervention without IVUS.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Symptomatic LE PAD - Rutherford Class 2-5 * Angiographic evidence of \>50% stenosis * Undergoing LE peripheral artery intervention * Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee arteries (target lesions extending into the abdominal aorta and inframalleolar BTK may be included). Exclusion Criteria: * Prior intervention at the target lesion within 6 months * Target lesion is abdominal aorta or inframalleolar BTK arteries

Locations (6)

Baylor Scott & White The Heart Hospital - Dallas

Dallas, Texas, United States

RECRUITING

Baylor Scott & White The Heart Hospital - Fort Worth

Fort Worth, Texas, United States

NOT_YET_RECRUITING

Baylor Scott & White The Heart Hospital - Mckinney

McKinney, Texas, United States

Outcomes

Primary Outcomes

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

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

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

Clinically driven-TLR (CD-TLR)

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

Time frame: From enrollment to 12 months

Amputation-free Survival

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

Time frame: From enrollment to 12 months

Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))

Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months.

Time frame: From enrollment to 12 months

Functional Status Improvement (Rutherford Class Improvement)

Central Contacts

Sarah Hale

CONTACT

469-814-4845 sarah.hale@bswhealth.org

Sarah Weideman

CONTACT

214-820-2927 sarah.weideman@bswhealth.org

Data from ClinicalTrials.gov

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