NCT01422343

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

March 28, 2011

Last Update Submit

September 8, 2014

Conditions

Peripheral Vascular Diseases

Keywords

peripheral arterial diseasecell-derived microparticlesimmunity, innateblood coagulation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with early re-stenosis post-angioplasty

    6 month post-angioplasty

Secondary Outcomes (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

    6 months post-angioplasty

Study Arms (1)

1

Procedure: percutaneous transluminal angioplasty femoro-popliteal

Interventions

percutaneous transluminal angioplasty femoro-poplitealPROCEDURE

percutaneous transluminal angioplasty femoro-popliteal

1

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (male and female) with peripheral arterial disease presenting at the angiology clinic, Bern University Hospital

You may qualify if:

  • male or female
  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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. No abstract available.

    PMID: 10666287BACKGROUND

  • 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. doi: 10.1161/01.cir.96.10.3534.

    PMID: 9396452BACKGROUND

  • 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. doi: 10.1161/01.cir.101.8.841.

    PMID: 10694520BACKGROUND

  • 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. doi: 10.1161/01.cir.0000036596.59665.c6.

    PMID: 12417540BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular DiseasesPeripheral Arterial DiseaseThrombosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesEmbolism and Thrombosis

Study Officials

  • Iris Baumgartner, DMD

    Bern University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2011

First Posted

August 23, 2011

Study Start

May 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 9, 2014

Record last verified: 2014-09