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

This study has been completed.
Sponsor:
Collaborator:
Swiss Heart Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00660634
First received: April 10, 2008
Last updated: April 25, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Peripheral Arterial Obstructive Disease
Intermittent Claudication
Procedure: Endovascular Revascularization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Angioplasty in Peripheral Arterial Disease on Endothelial Function

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Improvement of Flow-mediated Dilation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of white blood cell count [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: December 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: B
Experimental: A
Endovascular angioplasty/stenting
Procedure: Endovascular Revascularization
Angioplasty/Stenting of femoro-popliteal lesions
Other Name: Endovascular Revascularization

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 10, 2008
Last Updated: April 25, 2008
Health Authority: Switzerland: Federal Office of Public Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014