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Microparticles and the Risk of Re-stenosis Following Balloon Angioplasty in Patients With Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT01422343
Recruitment Status : Withdrawn (Shortage of personnel / main study initiator no longer available)
First Posted : August 23, 2011
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Although microparticles have been well-documented as mediators of inflammation and coagulation in various cardio-vascular disease events, it is currently not known how Percutaneous Transluminal Angioplasty (PTA) for peripheral arterial disease influences microparticle numbers, phenotype and distribution pre- and post interventionally and how they are related to or affect the incidence of early re-stenosis - or if indeed they may be used to predict patients at risk of early re-stenosis.

Condition or disease Intervention/treatment
Peripheral Vascular Diseases Procedure: percutaneous transluminal angioplasty femoro-popliteal

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Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Microparticles With Risk of Early Re-stenosis After Percutaneous Transluminal Angioplasty in Patients With Peripheral Arterial Disease
Study Start Date : May 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1 Procedure: percutaneous transluminal angioplasty femoro-popliteal
percutaneous transluminal angioplasty femoro-popliteal


Outcome Measures

Primary Outcome Measures :
  1. Number of participants with early re-stenosis post-angioplasty [ Time Frame: 6 month post-angioplasty ]

Secondary Outcome Measures :
  1. Number of and changes in circulating cell-derived microparticles, measured by flow cytometric analysis of peripheral blood samples, and correlation with early re-stenosis post-PTA [ Time Frame: 6 months post-angioplasty ]

Eligibility Criteria

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (male and female) with peripheral arterial disease presenting at the angiology clinic, Bern University Hospital
Criteria

Inclusion Criteria:

  • male or female
  • 60-85 years
  • femoro-popliteal stenosis
  • TASC B or C category
  • HBA1c <9%, if diabetic
  • creatinine <130µg/ml
  • blood pressure <160/95mmHg
  • thrombocyte aggregation inhibitors or coumarine derivatives

Exclusion Criteria

  • <60 or >85 years
  • stenosis not in femoro-popliteal axis
  • TASC A or D category
  • HBA1c >9%, if diabetic
  • creatinine >130µg/ml
  • blood pressure >160/95mmHg
  • major trauma
  • malignancy
  • anti-phospholipid syndrome
  • relevant hepatic disease
  • major operation within 1 month of enrolment
Contacts and Locations

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): NCT01422343


Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Principal Investigator: Iris Baumgartner, DMD Bern University Hospital
More Information

Publications:
Responsible Party: Prof. Iris Baumgartner, Bern University Hospital
ClinicalTrials.gov Identifier: NCT01422343     History of Changes
Other Study ID Numbers: 068/09
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by University Hospital Inselspital, Berne:
peripheral arterial disease
cell-derived microparticles
immunity, innate
blood coagulation

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases