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

NCT00424450 | Completed

• 1 other identifier: C01-2006
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

contrast ultrasound; muscle perfusion

Study Arms (1)

PAD patients

30 PAD patients

Procedure: lower limb artery bypass surgery; Procedure: percutaneous angioplasty (PTA)

Interventions

lower limb artery bypass surgery PROCEDURE

bypass of severe atherosclerotic vascular lesion

Also known as: half of the included PAD patients undergo surgery

PAD patients

percutaneous angioplasty (PTA) PROCEDURE

PTA of severe atherosclerotic lesion

Also known as: half of included PAD patients undergo PTA

PAD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PAD patients

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Hospital of Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (1)

• 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. doi: 10.1093/eurheartj/ehi636. Epub 2005 Nov 24.

  PMID: 16308326 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Christoph Hehrlein, MD

  Department of Cardiology and Angiology, University Hospital of Freiburg, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 19, 2007
• Study Start: October 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

DE (1)