Does the use of intravascular ultrasound improve outcomes of endovascular interventional procedures for peripheral vascular disease of the superficial femoral artery or popliteal artery?
Not Applicable
Completed
- Conditions
- Peripheral Arterial DiseaseCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12614000006640
- Lead Sponsor
- Department of Vascular Surgery, Flinders Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Patients with a stenotic or occlusive lesion(s) in the SFA or popliteal artery in whom endovascular intervention with angioplasty +/- stenting is the most appropriate treatment option based on presenting symptoms, lesion characteristics and medically suitability.
Exclusion Criteria
Patients who are unable to give informed consent due to language difficulties, or physical and/or mental incapacity.
Allergy to iodine based contrast media.
Very short life expectancy (>6 months)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Binary restenosis at 12 months- defined as <50% restenosis in the treated segment of the artery. The duplex criteria is a peak velocity ratio >/= 2.4. Duplex ultrasound will be used as the standard non-invasive surveillance modality. Regular surveillance scans will be performed at 3,6 and 12 months, CT, MRI or angiography may also be used if performed for clinical requirements and a 50% reduction in lumen will indicate restenosis in these cases[1, 3, 6 and 12 months post procedure]
- Secondary Outcome Measures
Name Time Method Target lesion revascularisation (TLR) rate - defined as the number of re-interventions performed on treated lesions divided by the total number of primary treatments[One year post procedure];Major adverse events (MAEs) - defined as death, cardiovascular event (MI and stroke), target lesion revascularisation (TLR) and major amputation[One year post procedure]