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Objective Evaluation of Proximal Ischemia - Article


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Clinical Trial: Objective Evaluation of Proximal Ischemia

This study is currently recruiting patients.
Verified by University Hospital Angers September 2005

Sponsors and Collaborators: University Hospital Angers
Sanofi-Synthelabo
Société Française de Médecine Vasculaire
Information provided by: University Hospital Angers
ClinicalTrials.gov Identifier: NCT00152737

Purpose

The whole study is divided in 4 parallel protocols.The first protocole estimates the reliability of the technique through test-retest recordings. The second protol 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 protocole 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 protocole 2 is that TcpO2 at exercise is significantly improved after surgery at the aortic and primary iliac artery. The hypothesis for protocole 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.

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

MedlinePlus related topics:  Leg Injuries and Disorders;   Peripheral Vascular Diseases

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study

Official Title: Effet Des Gestes De Revascularisation à l''''étage Proximal

Further Study Details: 

Expected Total Enrollment:  165

Study start: March 2004;  Expected completion: August 2006
Last follow-up: July 2006;  Data entry closure: August 2006

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

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Stage 4 LEAD
  • Aortic aneurysm
  • Acute coronary syndrom
  • claudication of documented non vascular origin (for protocoles 1-3 only)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00152737

Pierre ABRAHAM, MD, PhD      +33 (0) 2.41.35.36.89    piabraham@chu-angers.fr

France
      Laboratoire d''''explorations vasculaires, Angers,  49033,  France; Recruiting
Pierre Abraham, MD PhD  +33 (0) 2.41.35.36.89 

Study chairs or principal investigators

jean louis Saumet, MD PhD,  Study Chair,  University Hospital in Angers   
Pierre Abraham, MD PhD,  Principal Investigator,  University Hospital in Angers   
Bernard Enon, MD,  Study Chair,  University Hospital in Angers   

More Information

Study ID Numbers:  PHRC 03-01
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00152737
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13


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