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

Primary Purpose

Peripheral Arterial Obstructive Disease, Intermittent Claudication

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Endovascular Revascularization
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Obstructive Disease focused on measuring Peripheral arterial obstructive disease, Intermittent Claudication, Endovascular treatment, Flow-mediated dilation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    B

    A

    Arm Description

    Endovascular angioplasty/stenting

    Outcomes

    Primary Outcome Measures

    Improvement of Flow-mediated Dilation

    Secondary Outcome Measures

    Improvement of white blood cell count

    Full Information

    First Posted
    April 10, 2008
    Last Updated
    April 25, 2008
    Sponsor
    Insel Gruppe AG, University Hospital Bern
    Collaborators
    Swiss Heart Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00660634
    Brief Title
    Angioplasty in Peripheral Arterial Disease and Endothelial Function
    Acronym
    PTA-PAD-FMD
    Official Title
    The Effect of Angioplasty in Peripheral Arterial Disease on Endothelial Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Insel Gruppe AG, University Hospital Bern
    Collaborators
    Swiss Heart Foundation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Obstructive Disease, Intermittent Claudication
    Keywords
    Peripheral arterial obstructive disease, Intermittent Claudication, Endovascular treatment, Flow-mediated dilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    B
    Arm Type
    No Intervention
    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Endovascular angioplasty/stenting
    Intervention Type
    Procedure
    Intervention Name(s)
    Endovascular Revascularization
    Intervention Description
    Angioplasty/Stenting of femoro-popliteal lesions
    Primary Outcome Measure Information:
    Title
    Improvement of Flow-mediated Dilation
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Improvement of white blood cell count
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc J Husmann, MD
    Organizational Affiliation
    Angiology Division, University Hospital of Berne, Switzerland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Angioplasty in Peripheral Arterial Disease and Endothelial Function

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