Assessment of Bypass Surgery and Balloon Angioplasty Effects in Peripheral Arterial Disease Using Contrast Ultrasound
Recruitment status was: Active, not recruiting
|Peripheral Arterial Disease||Procedure: lower limb artery bypass surgery Procedure: percutaneous angioplasty (PTA)|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging (REVASC-PI)|
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||July 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
30 PAD patients
Procedure: lower limb artery bypass surgery
bypass of severe atherosclerotic vascular lesion
Other Name: half of the included PAD patients undergo surgeryProcedure: percutaneous angioplasty (PTA)
PTA of severe atherosclerotic lesion
Other Name: half of included PAD patients undergo PTA
Contrast ultrasound perfusion imaging (CUPI) was developed at the University Hospital of Freiburg, Germany in 2005 for the assessment of skeletal muscle perfusion deficits in peripheral arterial disease (PAD). It has been reported previously by the investigators that the contrast agent wash-in is significantly prolonged in PAD with respect to the extent of disease and with respect to the degree of collateralization.
The goal of this study is to examine the effect of revascularization procedures on muscular perfusion in 15 PAD patients undergoing lower limb artery bypass surgery and 15 PAD patients undergoing percutaneous angioplasty (PTA) before and after intervention. Based on the data from a pilot study, a power calculation for an alpha = 5% with a power of 80% and an assumed standard deviation of 10 s yielded a necessary patient number of 29 per group to detect a decrease in wash-in time of 7.5 s. In this intra-individual comparison we aim to compare 30 patients pre with the same 30 patients post revascularization.
We hypothesize 1) that the contrast agent wash-in in the target muscle will significantly improve after revascularization and 2) that standard non-invasive tests such ankle-brachial index (ABI) will not correlate with the CUPI findings. The results of this trial will help to further understand the diagnostic accuracy of CUPI in quantifying limb muscle perfusion deficits.
Patients with symptomatic PAD and an indication for revascularization will undergo CUPI less than 8 weeks prior and less than 3 weeks after the revascularization procedure. A second follow-up CUPI examination is performed 3 - 6 months after the revascularization procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424450
|University Hospital of Freiburg|
|Freiburg, Germany, 79106|
|Study Chair:||Christoph Hehrlein, MD||Department of Cardiology and Angiology, University Hospital of Freiburg, Germany|