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Objective Evaluation of Proximal Ischemia

Effet Des Gestes de Revascularisation à l'étage Proximal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00152737
Enrollment
165
Registered
2005-09-09
Start date
2004-03-31
Completion date
2008-07-31
Last updated
2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication, Peripheral Vascular Diseases

Keywords

Intermittent Claudication, Peripheral Vascular Diseases, Blood Gas Monitoring, Transcutaneous, Surgery

Brief 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

Detailed description

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

Interventions

PROCEDUREExercise test with Transcutaneous oxygene pressure

Ce marked devices

PROCEDUREAnkle and arm pressure values

one test before and one test after surgery

Sponsors

Sanofi-Synthelabo
CollaboratorINDUSTRY
Société Française de Médecine Vasculaire
CollaboratorUNKNOWN
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026