Status:
COMPLETED
Assessment of Bypass Surgery and Balloon Angioplasty Effects in Peripheral Arterial Disease Using Contrast Ultrasound
Lead Sponsor:
University Hospital Freiburg
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
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...
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 disea...
Eligibility Criteria
Inclusion
- male or females \> 18 years old
- PAD Fontaine stages IIb, III or IV
- conventional angiography or magnetic resonance angiography
- a severe lesion (≥80% stenosis with a peak velocity ratio intrastenotic / prestenotic ≥4.0 in Duplex ultrasound or occlusion) has to be present in the common or external iliac, common or superficial femoral, popliteal or one or more infrapopliteal arteries, which is accessible to revascularization
- indication for revascularization, i.e. lower limb artery bypass surgery or PTA (based on the treating physician's decision)
- revascularization appointed within the next 6 weeks of study inclusion
- patients, who have the ability to understand the requirements of the study, provide written informed consent, abide by the study requirements, and agree to return for the required follow-up
Exclusion
- failed or incomplete revascularization
- patients with chronic heart failure NYHA IV
- patients with acute coronary syndrome
- patients with severe pulmonary hypertension
- patients who are assigned to conservative PAD treatment (according to the treating physician's decision)
- refusal or inability to give informed consent
- patients who are enrolled into another clinical trial
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00424450
Start Date
October 1 2006
End Date
July 1 2009
Last Update
October 11 2018
Active Locations (1)
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1
University Hospital of Freiburg
Freiburg im Breisgau, Germany, 79106