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

This study has been withdrawn prior to enrollment.
(Shortage of personnel / main study initiator no longer available)
Sponsor:
Collaborator:
University of Bern
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01422343
First received: March 28, 2011
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention
Peripheral Vascular Diseases
Procedure: percutaneous transluminal angioplasty femoro-popliteal

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of participants with early re-stenosis post-angioplasty [ Time Frame: 6 month post-angioplasty ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: percutaneous transluminal angioplasty femoro-popliteal
percutaneous transluminal angioplasty femoro-popliteal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 28, 2011
Last Updated: September 8, 2014
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on November 20, 2014