A Meta-analysis of Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease
This study has been completed.
Sponsor:
Catholic University of the Sacred Heart
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01036048
First received: December 7, 2009
Last updated: December 18, 2009
Last verified: December 2009
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Purpose
A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease.
| Condition | Intervention |
|---|---|
|
Saphenous Vein Graft Disease |
Device: drug eluting stent Device: bare metal stent |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis |
Further study details as provided by Catholic University of the Sacred Heart:
Primary Outcome Measures:
- death [ Time Frame: years depending from studies retrieved ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- myocardial infarction [ Time Frame: years depending from study retrieved ] [ Designated as safety issue: No ]
- target vessel revascularization [ Time Frame: years depending from study retrieved ] [ Designated as safety issue: No ]
| Enrollment: | 5806 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
cabg disease
pts with saphenous vein graft disease
|
Device: drug eluting stent
pts with cabg disease treated with drug eluting stent
Other Name: des
Device: bare metal stent
pts with cabg disease treated with bare metal stent
Other Name: bms
|
Detailed Description:
To compare outcomes (death, myocardial infarction, target vessel revascularization) of drug eluting stent versus bare metal stent in saphenous vein graft disease.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with CABG disease
Criteria
Inclusion Criteria:
- CABG disease
- randomized studies
- not randomized studies
Exclusion Criteria:
- studies reporting composite and not single endpoints, duplicate reporting
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036048
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
| Principal Investigator: | ALESSANDRO LUPI, MD | OSPEDALE MAGGIORE NOVARA |
| Principal Investigator: | ELIANO NAVARESE, MD | CATHOLIC UNIVERSITY OF SACRED HEART |
More Information
No publications provided by Catholic University of the Sacred Heart
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | navarese, Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier: | NCT01036048 History of Changes |
| Other Study ID Numbers: | N28LBCF80-07 |
| Study First Received: | December 7, 2009 |
| Last Updated: | December 18, 2009 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Catholic University of the Sacred Heart:
|
saphenous vein graft stent |
ClinicalTrials.gov processed this record on May 16, 2013