A Meta-analysis of Drug Eluting Stents Versus Bare Metal... | NCT01036048

Studies
A Meta-analysis of Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease

NCT01036048

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

Dec 21, 2009Estimated

Enrollment

5,806Actual

Phase

Not provided

Conditions

Saphenous Vein Graft Disease

Interventions

drug eluting stent
bare metal stent

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 18, 2009

First Posted Date

Dec 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2009

Last Update Posted Date

Dec 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

To compare outcomes (death, myocardial infarction, target vessel revascularization) of drug eluting stent versus bare metal stent in saphenous vein graft disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,806Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cabg disease		pts with saphenous vein graft disease	Device: drug eluting stent Device: bare metal stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drug eluting stent	Device	pts with cabg disease treated with drug eluting stent	cabg disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death		years depending from studies retrieved

Secondary Outcomes

Measure	Description	Time Frame
myocardial infarction		years depending from study retrieved
target vessel revascularization		years depending from study retrieved

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CABG disease
randomized studies
not randomized studies

Exclusion Criteria:

studies reporting composite and not single endpoints, duplicate reporting

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with CABG disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ALESSANDRO LUPI, MD	OSPEDALE MAGGIORE NOVARA	Principal Investigator
ELIANO NAVARESE, MD	CATHOLIC UNIVERSITY OF SACRED HEART	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21173499	Derived	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.

ID	Term
D015607	Stents
D019736	Prostheses and Implants
D004864	Equipment and Supplies