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Objective Evaluation of Proximal Ischemia

U

University Hospital, Angers

Status

Completed

Conditions

Peripheral Vascular Diseases
Intermittent Claudication

Treatments

Procedure: Ankle and arm pressure values
Procedure: Exercise test with Transcutaneous oxygene pressure

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00152737
PHRC 03-01

Details and patient eligibility

About

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

Full 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

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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