Objective Evaluation of Proximal Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152737
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : July 17, 2015
Société Française de Médecine Vasculaire
Information provided by (Responsible Party):
University Hospital, Angers

September 8, 2005
September 9, 2005
July 17, 2015
March 2004
July 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00152737 on Archive Site
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Objective Evaluation of Proximal Ischemia
Effet Des Gestes de Revascularisation à l'étage Proximal

The whole study is divided in 4 parallel protocols. The first protocol estimates the reliability of the technique through test-retest recordings. The second protocol aims to prove that exercise Tcpo2 is efficient to estimate the benefit of proximal revascularisation on proximal and distal ischemia in patients suffering stage two lower extremity arterial disease. The third protocol aims at estimating with exercise tcpo2 the eventual apparison of proximal ischemia after aorto-bi-femoral bypasses. The last protocol is a transversal study of patients with aorto-bi-femoral bypasses aiming to analyse the presence of proximal and distal symptoms and ischemia.

The hypothesis for protocol 2 is that TcpO2 at exercise is significantly improved after surgery at the aortic and primary iliac artery. The hypothesis for protocols 3 and 4 relates on the hypothesis that a significant number of patients benefiting aorto-bi-femoral bypass suffer isolated proximal pain/ischemia after surgery.

Amendement to the project has been recently validated to study the neurologic and bone complication of chronic vascular ischemia

Patients included are submitted to:

San Diego Claudication Questionnaire before and during the treadmill test Treadmill test(s) through the Strandness procedure (2MPh 10% slope) Transcutaneous oxygen pressure recording before during and after exercise Ankle and brachial pressure measurements. Neurologic investigation with Quantitative sensory Testing (QST) and neurophysiological tests for patients included in the sub-group analysing neurologic complication Whole body densitometry for patients included in the sub-group analysing osteo-articular complications

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients with claudication
  • Intermittent Claudication
  • Peripheral Vascular Diseases
  • Procedure: Exercise test with Transcutaneous oxygene pressure
    Ce marked devices
  • Procedure: Ankle and arm pressure values
    one test before and one test after surgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • protocol 1 - 3 stage 2 claudication
  • Protocols 2 & 3 : Indication for surgery
  • protocol 4 : Patent aorto bio femoral bypass for more than 4 months
  • Ability to perform a treadmill test

Exclusion Criteria:

  • Stage 4 LEAD
  • Aortic aneurysm
  • Acute coronary syndrom
  • claudication of documented non vascular origin (for protocols 1-3 only)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
PHRC 03-01
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University Hospital, Angers
University Hospital, Angers
  • Sanofi-Synthelabo
  • Société Française de Médecine Vasculaire
Study Chair: jean louis Saumet, MD PhD University Hospital in Angers
Principal Investigator: Pierre Abraham, MD PhD University Hospital in Angers
Study Chair: Bernard Enon, MD University Hospital in Angers
University Hospital, Angers
July 2015