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
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
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
NCT ID
NCT00660634
First Posted
April 10, 2008
Last Updated
April 25, 2008
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss Heart Foundation
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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