A Randomized, Open Label, Investigator-Initiated Trial comparing Intravascular Ultrasound-Guided Atherectomy to Angiography-Guided Atherectomy in Peripheral Vascular Interventions for TASC's A, B, C lesions. (UTOPIA trial)
ID Number 10-0042Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to compare the results and the overall change in a patient's health status after treatment with the SilverHawk atherectomy device using two imaging methods. Subjects will be divided into two groups and a comparison will be made between (1) standard angiographic treatment and (2) standard angiographic imaging plus (+) intravascular ultrasound (IVUS) guided treatment. This study will also analyze data from virtual histology (VH) to determine whether the research team can identify lesion types (plaque material) that can be treated more effectively via directional atherectomy. IVUS is an imaging modality that allows the study team to 'see' and characterize the plaque because we can visualize the plaque in three dimensions.
1. Intravascular ultrasound (IVUS) guided atherectomy will result in better American Heart Association (AHA) clinical evaluation for success at six and twelve months after procedure when compared to standard angiography-based atherectomy.
2. Virtual histology (VH) will identify lesion types that are most amenable to atherectomy.
Participation by participant is expected to last one year. All study subjects targeted to be enrolled by 2013, followed by primary data analysis expected to last one month. The number of people expected to take part in this research study at this site is 130.
The follow-up meetings will last 30 minutes and will occur at 3-month, 6-month and 12-months after treatment procedure. During these follow-up visits, they will have a repeat Duplex Ultrasound of the leg performed to determine vessel patency. ABI/TBI measurements, Rutherford clinical classification and completion of a quality of left/walking impairment questionnaire.
There are no extra costs for participation in the study.
Arthur Tarricone, CRC
Recruiting Patients: Yes