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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

University of Bern

Information provided by:

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT01422343

First received: March 28, 2011

Last updated: August 22, 2011

Last verified: August 2011

History of Changes

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:

MedlinePlus related topics: Angioplasty Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

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 ]

Estimated Enrollment:	80
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422343

Locations

Switzerland
University Clinic und Policlinic for Angiology, Bern University Hospital
Bern, Switzerland, 3010
Institute of Pathology, University of Bern
Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

University of Bern

Investigators

Principal Investigator:

Iris Baumgartner, DMD

Bern University Hospital

More Information

Publications:

Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg. 2000 Jan;31(1 Pt 2):S1-S296. Review. No abstract available.

Nieuwland R, Berckmans RJ, Rotteveel-Eijkman RC, Maquelin KN, Roozendaal KJ, Jansen PG, ten Have K, Eijsman L, Hack CE, Sturk A. Cell-derived microparticles generated in patients during cardiopulmonary bypass are highly procoagulant. Circulation. 1997 Nov 18;96(10):3534-41.

Mallat Z, Benamer H, Hugel B, Benessiano J, Steg PG, Freyssinet JM, Tedgui A. Elevated levels of shed membrane microparticles with procoagulant potential in the peripheral circulating blood of patients with acute coronary syndromes. Circulation. 2000 Feb 29;101(8):841-3.

Diamant M, Nieuwland R, Pablo RF, Sturk A, Smit JW, Radder JK. Elevated numbers of tissue-factor exposing microparticles correlate with components of the metabolic syndrome in uncomplicated type 2 diabetes mellitus. Circulation. 2002 Nov 5;106(19):2442-7.

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:	August 22, 2011
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:

Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 22, 2013

To Top