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Clinical Trial: Objective Evaluation of Proximal Ischemia
This study is currently recruiting patients.
Verified by University Hospital Angers September 2005
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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
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
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
France
Laboratoire d''''explorations vasculaires, Angers, 49033, France; Recruiting
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
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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