Peripheral Arterial Disease, Lower Extremity Arterial Disease
Conditions
Keywords
Intravascular Ultrasound, Angioplasty, Endovascular Treatment
Brief summary
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.
Detailed description
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).
Interventions
pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement
DEVICEAngiographic-guided Intervention
Standard angiography-guided intervention without IVUS.
Sponsors
Baylor Research Institute
Philips Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single-blind
Intervention model description
Prospective randomized controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | From enrollment to 6 months | Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Collected from index procedure | 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. |
| Procedural Success | Collected from Index procedure | 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. |
| Clinically driven-TLR (CD-TLR) | From enrollment to 12 months | Clinically driven-target limb revascularization. Information collected from the medical record. |
| Amputation-free Survival | From enrollment to 12 months | Defined as no evidence of amputation. Information is collected from the medical record |
| Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6)) | From enrollment to 12 months | Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months. |
| Functional Status Improvement (Rutherford Class Improvement) | From enrollment to 12 months | Rutherford class determined by physician and collected from the medical record. |
| Cost Effectiveness | Evaluated at 12 months | This analysis will calculate total cost-effectiveness by comparing costs between the two groups. Total cost will include the initial procedural cost, costs related to complications, and costs of any repeat reinterventions during follow-up. |
Countries
United States
Contacts
CONTACTSarah Hale
CONTACTSarah Weideman
PRINCIPAL_INVESTIGATORSubhash Banerjee, MD
Baylor Scott & White Research Institute
Outcome results
None listed