NCT00152737

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

4.3 years

First QC Date

September 8, 2005

Last Update Submit

July 16, 2015

Conditions

Intermittent ClaudicationPeripheral Vascular Diseases

Keywords

Intermittent ClaudicationPeripheral Vascular DiseasesBlood Gas Monitoring, TranscutaneousSurgery

Interventions

Exercise test with Transcutaneous oxygene pressurePROCEDURE

Ce marked devices

Ankle and arm pressure valuesPROCEDURE

one test before and one test after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with claudication

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'explorations vasculaires

Angers, 49033, France

Location

Related Publications (3)

  • Jaquinandi V, Picquet J, Bouye P, Saumet JL, Leftheriotis G, Abraham P. High prevalence of proximal claudication among patients with patent aortobifemoral bypasses. J Vasc Surg. 2007 Feb;45(2):312-8. doi: 10.1016/j.jvs.2006.09.050.

    PMID: 17264010RESULT

  • Jaquinandi V, Abraham P, Picquet J, Paisant-Thouveny F, Leftheriotis G, Saumet JL. Estimation of the functional role of arterial pathways to the buttock circulation during treadmill walking in patients with claudication. J Appl Physiol (1985). 2007 Mar;102(3):1105-12. doi: 10.1152/japplphysiol.00912.2006. Epub 2006 Nov 16.

    PMID: 17110509RESULT

  • Ouedraogo N, Feuilloy M, Mahe G, Leftheriotis G, Saumet JL, Abraham P. Chest tcpO2 changes during constant-load treadmill walking tests in patients with claudication. Physiol Meas. 2011 Feb;32(2):181-94. doi: 10.1088/0967-3334/32/2/003. Epub 2010 Dec 22.

    PMID: 21178246DERIVED

MeSH Terms

Conditions

Intermittent ClaudicationPeripheral Vascular Diseases

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • jean louis Saumet, MD PhD

    University Hospital in Angers

    STUDY CHAIR

  • Pierre Abraham, MD PhD

    University Hospital in Angers

    PRINCIPAL INVESTIGATOR

  • Bernard Enon, MD

    University Hospital in Angers

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

March 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

FR(1)