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Objective Evaluation of Proximal Ischemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152737
First Posted: September 9, 2005
Last Update Posted: July 17, 2015
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.
Collaborators:
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Information provided by (Responsible Party):
University Hospital, Angers
  Purpose

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


Condition Intervention
Intermittent Claudication Peripheral Vascular Diseases Procedure: Exercise test with Transcutaneous oxygene pressure Procedure: Ankle and arm pressure values

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effet Des Gestes de Revascularisation à l'étage Proximal

Further study details as provided by University Hospital, Angers:

Enrollment: 165
Study Start Date: March 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Exercise test with Transcutaneous oxygene pressure
    Ce marked devices
    Procedure: Ankle and arm pressure values
    one test before and one test after surgery
Detailed Description:

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

  Eligibility

Information from the National Library of Medicine

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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
patients with claudication
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00152737


Locations
France
Laboratoire d'explorations vasculaires
Angers, France, 49033
Sponsors and Collaborators
University Hospital, Angers
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Investigators
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00152737     History of Changes
Other Study ID Numbers: PHRC 03-01
First Submitted: September 8, 2005
First Posted: September 9, 2005
Last Update Posted: July 17, 2015
Last Verified: July 2015

Keywords provided by University Hospital, Angers:
Intermittent Claudication
Peripheral Vascular Diseases
Blood Gas Monitoring, Transcutaneous
Surgery

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms


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