Objective Evaluation of Proximal Ischemia

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

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Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire d'explorations vasculaires

Angers, 49033, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise test with Transcutaneous oxygene pressure

Procedure

Ce marked devices

Ankle and arm pressure values

Procedure

one test before and one test after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

Sanofi-Synthelabo
Société Française de Médecine Vasculaire

Registry information

Official study title

Effet Des Gestes de Revascularisation à l'étage Proximal

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Sep 9, 2005
Registry last updated: Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed