Angioplasty in Peripheral Arterial Disease and Endothelial Function

Phase 4

Completed

• Conditions: Peripheral Arterial Obstructive Disease; Intermittent Claudication
• Interventions: Procedure: Endovascular Revascularization

• Registration Number: NCT00660634
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

To investigate whether endovascular revascualrization of infrainguinal arterial obstructive disease has an effect on brachial artery reactivity

Detailed Description

Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis affecting a large proportion of the aged population. It is associated with a more or less severe impairment in functional activity and with an increased risk of future cardiovascular events. In PAD patients, an increased inflammatory status and a depressed endothelial function, assessed as flow-mediated dilation of the brachial artery have been demonstrated. Moreover, a prognostic value has been found in PAD patients for both inflammatory parameter and flow-mediated dilation (FMD). One of the reasons of the increased inflammatory activation and endothelial dysfunction in PAD patients could be the ischemia-reperfusion injury associated with intermittent claudication. The hypothesis is that repeated episodes of acute inflammation and endothelial dysfunction following ischemia-reperfusion injury linked to intermittent claudication could be in part responsible for the increased inflammatory status and chronically depressed endothelial dysfunction of these patients. Taking into account these considerations, it is reasonable to assume that the correction of leg ischemia by interventional procedure, such as peripheral transluminal angioplasty (PTA) should determine a reduction in inflammatory mediators and an improvement in endothelial function.

The study is a prospective, open, randomised, controlled, single-centre, follow-up evaluation, assessing the efficacy of peripheral catheter interventions in patients with symptomatic PAD on endothelial dysfunction and plasmatic procoagulant activity. Patients will be randomly assigned to immediate revascularization or to no treatment for one month. The assessment of parameters (brachial artery flow-mediated and nitrate-mediated dilation, plasma levels of C reactive protein, fibrinogen, microparticles and coagulation factors) will be performed at baseline and after 4 weeks in both, patients undergoing interventional procedures and in those, who will not be treated.

Study Timeline

• Study Start: 2004-12
• Status Verified: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-17
• Last Update Submitted: 2008-04-25
• Last Update Posted: 2008-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Peripheral arterial disease
• femoro-popliteal lesion
• successful endovascular treatment of lesion

Exclusion Criteria

• persistent claudication after revascularization in arm A
• inflammatory or neoplastic disease
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Endovascular Revascularization	Endovascular angioplasty/stenting

Primary Outcome Measures

Name	Time	Method
Improvement of Flow-mediated Dilation	4 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement of white blood cell count	4 weeks