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| 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 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 Procedure: San diego claudication questionnaire |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study |
| Official Title: | Effet Des Gestes de Revascularisation à l'étage Proximal |
| Estimated Enrollment: | 165 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | July 2008 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pierre ABRAHAM, MD, PhD | +33 (0) 2.41.35.36.89 | piabraham@chu-angers.fr |
| France | |
| Laboratoire d'explorations vasculaires | Recruiting |
| Angers, France, 49033 | |
| Contact: Pierre Abraham, MD PhD +33 (0) 2.41.35.36.89 | |
| 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
| Study ID Numbers: | PHRC 03-01 |
| Study First Received: | September 8, 2005 |
| Last Updated: | March 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00152737 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Intermittent Claudication Peripheral Vascular Diseases Blood Gas Monitoring, Transcutaneous Surgery |
|
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases |
Intermittent Claudication Arteriosclerosis Flatulence Ischemia |
|
Arterial Occlusive Diseases Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases |
Intermittent Claudication Cardiovascular Diseases Arteriosclerosis |
