Peripheral Arterial Disease Clinical Trial
Official title:
Assessment of Revascularization Effects in Peripheral Arterial Disease Using Contrast Ultrasound Tissue Perfusion Imaging (REVASC-PI)
NCT number | NCT00424450 |
Other study ID # | C01-2006 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2006 |
Est. completion date | July 2009 |
Verified date | October 2018 |
Source | University Hospital Freiburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Freiburg | Freiburg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Freiburg |
Germany,
Duerschmied D, Olson L, Olschewski M, Rossknecht A, Freund G, Bode C, Hehrlein C. Contrast ultrasound perfusion imaging of lower extremities in peripheral arterial disease: a novel diagnostic method. Eur Heart J. 2006 Feb;27(3):310-5. Epub 2005 Nov 24. — View Citation
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