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Assessment of Bypass Surgery and Balloon Angioplasty Effects in Peripheral Arterial Disease Using Contrast Ultrasound

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ClinicalTrials.gov Identifier: NCT00424450
Recruitment Status : Unknown
Verified June 2008 by University Hospital Freiburg.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2007
Last Update Posted : June 6, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Procedure: lower limb artery bypass surgery Procedure: percutaneous angioplasty (PTA)

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 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.

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
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
Primary Completion Date : January 2008
Estimated Study Completion Date : July 2008

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
PAD patients
30 PAD patients
Procedure: lower limb artery bypass surgery
bypass of severe atherosclerotic vascular lesion
Other Name: half of the included PAD patients undergo surgery
Procedure: percutaneous angioplasty (PTA)
PTA of severe atherosclerotic lesion
Other Name: half of included PAD patients undergo PTA

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PAD patients

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424450

University Hospital of Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Study Chair: Christoph Hehrlein, MD Department of Cardiology and Angiology, University Hospital of Freiburg, Germany
More Information

Responsible Party: C. Hehrlein, MD, University Hospital of Freiburg
ClinicalTrials.gov Identifier: NCT00424450     History of Changes
Other Study ID Numbers: C01-2006
First Posted: January 19, 2007    Key Record Dates
Last Update Posted: June 6, 2008
Last Verified: June 2008

Keywords provided by University Hospital Freiburg:
contrast ultrasound
muscle perfusion

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases