Saphenous Vein Graft DiseaseNCT01036048
A Meta-analysis of Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease
An observational study of Saphenous Vein Graft Disease, run by Catholic University of the Sacred Heart.
Trial summary
A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Saphenous Vein Graft Disease
- What is being tested?
- drug eluting stent and bare metal stent
- Type of treatment
- Medical device
- How many people
- 5,806 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with CABG disease
Who may be able to join
- CABG disease
- randomized studies
- not randomized studies
Who cannot join
- studies reporting composite and not single endpoints, duplicate reporting
About this study
Official title: Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis
A meta-analysis to compare outcomes of drug eluting stents (DES) versus bare metal stent (BMS) in saphenous vein graft (SVG) disease.
Read the detailed description
To compare outcomes (death, myocardial infarction, target vessel revascularization) of drug eluting stent versus bare metal stent in saphenous vein graft disease.
- Conditions
- Saphenous Vein Graft Disease
- Being tested
- drug eluting stent, bare metal stent
- Keywords
- saphenous vein graft, stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug eluting stentDevice
Also called des
pts with cabg disease treated with drug eluting stent
bare metal stentDevice
Also called bms
pts with cabg disease treated with bare metal stent
| Study group | Role | What they receive |
|---|---|---|
| cabg disease | pts with saphenous vein graft disease Receives: Device: drug eluting stent; Device: bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: years depending from studies retrieved
Secondary outcomes (2)
myocardial infarction
Measured: years depending from study retrieved
target vessel revascularization
Measured: years depending from study retrieved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Saphenous Vein Graft DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 5,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- ALESSANDRO LUPI, MD, Principal investigator, OSPEDALE MAGGIORE NOVARAELIANO NAVARESE, MD, Principal investigator, CATHOLIC UNIVERSITY OF SACRED HEART
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036048
- Sponsor's protocol ID
- N28LBCF80-07
- Status last verified
- Dec 2009
- First submitted
- 7 Dec 2009
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21173499
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis
- ClinicalTrials.gov ID
- NCT01036048
- Acronym / sponsor ID
- N28LBCF80-07
- Conditions
- Saphenous Vein Graft Disease
- Keywords
- saphenous vein graft, stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,806 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cabg disease | – | Device: drug eluting stent, Device: bare metal stentpts with saphenous vein graft disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with CABG disease
Key inclusion criteria (3 listed)
- CABG disease
- randomized studies
- not randomized studies
Key exclusion criteria (1 listed)
- studies reporting composite and not single endpoints, duplicate reporting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug eluting stentAlso: despts with cabg disease treated with drug eluting stent | Device | cabg disease |
| bare metal stentAlso: bmspts with cabg disease treated with bare metal stent | Device | cabg disease |
Primary outcome
death
Time frame: years depending from studies retrieved
2 secondary outcomes
myocardial infarction
Time frame: years depending from study retrieved
target vessel revascularization
Time frame: years depending from study retrieved
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2009.
- Derived from this study: PubMed 21173499Lupi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALESSANDRO LUPI, MD principal investigator
OSPEDALE MAGGIORE NOVARA
ELIANO NAVARESE, MD principal investigator
CATHOLIC UNIVERSITY OF SACRED HEART
Questions about this trial
What is this clinical trial studying?
An observational study of Saphenous Vein Graft Disease, run by Catholic University of the Sacred Heart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: years depending from studies retrieved). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2009.