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Angioplasty in Peripheral Arterial Disease and Endothelial Function (PTA-PAD-FMD)

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ClinicalTrials.gov Identifier: NCT00660634
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : April 28, 2008
Sponsor:
Collaborator:
Swiss Heart Foundation
Information provided by:
University Hospital Inselspital, Berne

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Obstructive Disease Intermittent Claudication Procedure: Endovascular Revascularization Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Angioplasty in Peripheral Arterial Disease on Endothelial Function
Study Start Date : December 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: B
Experimental: A
Endovascular angioplasty/stenting
Procedure: Endovascular Revascularization
Angioplasty/Stenting of femoro-popliteal lesions



Primary Outcome Measures :
  1. Improvement of Flow-mediated Dilation [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Improvement of white blood cell count [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660634


Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss Heart Foundation
Investigators
Principal Investigator: Marc J Husmann, MD Angiology Division, University Hospital of Berne, Switzerland

Responsible Party: Dr. med. Marc Husmann/Prof. I Baumgartner, Angiology Div. University Hospital of Berne
ClinicalTrials.gov Identifier: NCT00660634     History of Changes
Other Study ID Numbers: 85/2004
SHF2006
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 28, 2008
Last Verified: April 2008

Keywords provided by University Hospital Inselspital, Berne:
Peripheral arterial obstructive disease
Intermittent Claudication
Endovascular treatment
Flow-mediated dilation

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Arterial Occlusive Diseases
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms