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Objective Evaluation of Proximal Ischemia

NCT00152737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2015-07-17

No results posted yet for this study

Summary

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

Conditions

  • Intermittent Claudication
  • Peripheral Vascular Diseases

Interventions

PROCEDURE

Exercise test with Transcutaneous oxygene pressure

Ce marked devices

PROCEDURE

Ankle and arm pressure values

one test before and one test after surgery

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • Société Française de Médecine Vasculaire

    collaborator UNKNOWN

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • jean louis Saumet, MD PhD · University Hospital in Angers

  • Pierre Abraham, MD PhD · University Hospital in Angers

  • Bernard Enon, MD · University Hospital in Angers

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152737 on ClinicalTrials.gov