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Angioplasty in Peripheral Arterial Disease and Endothelial Function

NCT ID: NCT00660634

Last Updated: 2008-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Peripheral Arterial Obstructive Disease Intermittent Claudication

Keywords

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Peripheral arterial obstructive disease Intermittent Claudication Endovascular treatment Flow-mediated dilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

Group Type NO_INTERVENTION

No interventions assigned to this group

A

Endovascular angioplasty/stenting

Group Type EXPERIMENTAL

Endovascular Revascularization

Intervention Type PROCEDURE

Angioplasty/Stenting of femoro-popliteal lesions

Interventions

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Endovascular Revascularization

Angioplasty/Stenting of femoro-popliteal lesions

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Heart Foundation

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Angiology Div. University Hospital of Berne

Principal Investigators

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Marc J Husmann, MD

Role: PRINCIPAL_INVESTIGATOR

Angiology Division, University Hospital of Berne, Switzerland

Other Identifiers

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SHF2006

Identifier Type: -

Identifier Source: secondary_id

85/2004

Identifier Type: -

Identifier Source: org_study_id