Angioplasty in Peripheral Arterial Disease and Endothelial Function

Intermittent Claudication Clinical Trial

— PTA-PAD-FMD  

Official title:

The Effect of Angioplasty in Peripheral Arterial Disease on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660634
• Other study ID #: 85/2004
• Secondary ID: SHF2006
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2008
• Last updated: April 25, 2008
• Start date: December 2004
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Endovascular Revascularization
Angioplasty/Stenting of femoro-popliteal lesions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss Heart Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Flow-mediated Dilation		4 weeks	No
Secondary	Improvement of white blood cell count		4 weeks	No