NCT01036048

Brief Summary

A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,806

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Status
completed

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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
Last Updated

December 21, 2009

Status Verified

December 1, 2009

Enrollment Period

7 months

First QC Date

December 7, 2009

Last Update Submit

December 18, 2009

Conditions

Saphenous Vein Graft Disease

Keywords

saphenous vein graftstent

Outcome Measures

Primary Outcomes (1)

  • death

    years depending from studies retrieved

Secondary Outcomes (2)

  • myocardial infarction

    years depending from study retrieved

  • target vessel revascularization

    years depending from study retrieved

Study Arms (1)

cabg disease

pts with saphenous vein graft disease

Device: drug eluting stentDevice: bare metal stent

Interventions

drug eluting stentDEVICE

pts with cabg disease treated with drug eluting stent

Also known as: des
cabg disease
bare metal stentDEVICE

pts with cabg disease treated with bare metal stent

Also known as: bms
cabg disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with CABG disease

You may qualify if:

  • CABG disease
  • randomized studies
  • not randomized studies

You may not qualify if:

  • studies reporting composite and not single endpoints, duplicate reporting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lupi A, Navarese EP, Lazzero M, Sansa M, De Servi S, Serra A, Bongo AS, Buffon A. Drug-eluting stents vs. bare metal stents in saphenous vein graft disease. Insights from a meta-analysis of 7,090 patients. Circ J. 2011;75(2):280-9. doi: 10.1253/circj.cj-10-0186. Epub 2010 Dec 14.

    PMID: 21173499DERIVED

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • ALESSANDRO LUPI, MD

    OSPEDALE MAGGIORE NOVARA

    PRINCIPAL INVESTIGATOR

  • ELIANO NAVARESE, MD

    CATHOLIC UNIVERSITY OF SACRED HEART

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 21, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 21, 2009

Record last verified: 2009-12