Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424450
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2007-01-18
Brief Title:
Assessment of Bypass Surgery and Balloon Angioplasty Effects in Peripheral Arterial Disease Using Contrast Ultrasound
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging REVASC-PI
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Contrast ultrasound perfusion imaging CUPI is a novel tool for the assessment of muscle perfusion deficits in peripheral arterial disease PAD In this study we want to examine the effect of bypass surgery and balloon angioplasty on the calf muscle blood supply We hope find a new way of quantifying success or failure of invasive treatment strategies
Detailed Description:
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 75 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
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 75 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None