Objective Evaluation of Proximal Ischemia

Intermittent Claudication Clinical Trial

Official title:

Effet Des Gestes de Revascularisation à l'étage Proximal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152737
• Other study ID #: PHRC 03-01
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: July 16, 2015
• Start date: March 2004
• Est. completion date: July 2008

Study information

• Verified date: July 2015
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Procedure:
• Exercise test with Transcutaneous oxygene pressure
Ce marked devices
• Ankle and arm pressure values
one test before and one test after surgery

Locations

Country	Name	City	State
France	Laboratoire d'explorations vasculaires	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Sanofi-Synthelabo, Société Française de Médecine Vasculaire

Country where clinical trial is conducted

France, 

References & Publications (2)

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;10 — View Citation

Jaquinandi V, Picquet J, Bouyé 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. — View Citation