RestenosisNCT01466634
Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis
An observational study of Restenosis and Myocardial Infarction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Restenosis, Myocardial Infarction
- What is being tested?
- percutaneous coronary intervention with stent
- Type of treatment
- Surgery or procedure
- How many people
- 6,221 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2011to Oct 2011
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease with indication to percutaneous coronary intervention
Who may be able to join
- randomized studies
- studies reporting clinical outcomes as overall death and/or acute myocardial infarction and/or late stent thrombosis (ARC definition)[**] and/or target lesion revascularization and/or late lumen loss
- follow up period longer than 6 months.
Who cannot join
- duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
- inability to compute risk estimates due to absence of clinical event in one of the groups
- studies presenting composite major adverse cardiac event (MACE) and not individual end points.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients
Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease.
Read the detailed description
Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Previous studies suggested that BP-DES are at least as effective as durable polymer drug eluting stents (PP-DES). Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease. Medline and Web databases were searched for studies comparing BP-DES and PP-DES for obstructive coronary disease, reporting rates of overall mortality, target lesion revascularization (TLR), myocardial infarction (MI), binary restenosis and late lumen loss (LLL) with a follow-up ≥ 6 months. Odds ratios (ORs) will be computed from individual studies and pooled according to a fixed effect (e.g. inverse variance weighting) or random effect model in case of statistical heterogeneity. Given the a priori heterogeneous nature of the observational analyses, separate subgroup analysis of studies with PLA bioabsorbable polymer loaded with biolimus A19 (BP-BES) is prespecified.
- Conditions
- Restenosis, Myocardial Infarction
- Being tested
- percutaneous coronary intervention with stent
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary intervention with stentProcedure or surgery
patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES
| Study group | Role | What they receive |
|---|---|---|
| permanent polymer DES | Not described Receives: Procedure: percutaneous coronary intervention with stent | |
| bioabsorbable polymer DES | Not described Receives: Procedure: percutaneous coronary intervention with stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
late coronary lumen loss
Measured: 9 month
target lesion revascularization
Measured: 9 month
overall mortality
Measured: 1 year
Late stent thrombosis
Measured: 1 year
Myocardial Infarction
Measured: 1 year
Secondary outcomes (1)
Binary restenosis
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionOct 2011
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 RestenosisStudies 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
- 6,221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Alessandro Lupi, MD, Principal investigator, AOU Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466634
- Sponsor's protocol ID
- 010101
- Status last verified
- Nov 2011
- First submitted
- 24 Oct 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lupi A, Rognoni A, Secco GG, Lazzero M, Nardi F, Fattori R, Bongo AS, Agostoni P, Sheiban I. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: insights from a meta-analysis of 5,834 patients. Eur J Prev Cardiol. 2014 Apr;21(4):411-24. doi: 10.1177/2047487312467745. Epub 2012 Nov 14.
PubMed 23152364
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioabsorbable Versus Permanent Polymer Bare Metal Stents in Saphenous Vein Graft Disease: Insights From a Meta-analysis of 6221 Patients
- ClinicalTrials.gov ID
- NCT01466634
- Acronym / sponsor ID
- 010101
- Conditions
- Restenosis, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,221 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Nov 2011 (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.
Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease.
Detailed description
Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain. Previous studies suggested that BP-DES are at least as effective as durable polymer drug eluting stents (PP-DES). Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in obstructive coronary artery disease. Medline and Web databases were searched for studies comparing BP-DES and PP-DES for obstructive coronary disease, reporting rates of overall mortality, target lesion revascularization (TLR), myocardial infarction (MI), binary restenosis and late lumen loss (LLL) with a follow-up ≥ 6 months. Odds ratios (ORs) will be computed from individual studies and pooled according to a fixed effect (e.g. inverse variance weighting) or random effect model in case of statistical heterogeneity. Given the a priori heterogeneous nature of the observational analyses, separate subgroup analysis of studies with PLA bioabsorbable polymer loaded with biolimus A19 (BP-BES) is prespecified.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| permanent polymer DES | – | Procedure: percutaneous coronary intervention with stent |
| bioabsorbable polymer DES | – | Procedure: percutaneous coronary intervention with stent |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease with indication to percutaneous coronary intervention
Key inclusion criteria (3 listed)
- randomized studies
- studies reporting clinical outcomes as overall death and/or acute myocardial infarction and/or late stent thrombosis (ARC definition)[**] and/or target lesion revascularization and/or late lumen loss
- follow up period longer than 6 months.
Key exclusion criteria (3 listed)
- duplicate reporting (in which case the manuscript reporting the largest sample or the longest follow-up was selected)
- inability to compute risk estimates due to absence of clinical event in one of the groups
- studies presenting composite major adverse cardiac event (MACE) and not individual end points.
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 |
|---|---|---|
| percutaneous coronary intervention with stentpatients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES | Procedure or surgery | bioabsorbable polymer DES, permanent polymer DES |
Primary outcome
late coronary lumen loss
Time frame: 9 month
target lesion revascularization
Time frame: 9 month
overall mortality
Time frame: 1 year
Late stent thrombosis
Time frame: 1 year
Myocardial Infarction
Time frame: 1 year
1 secondary outcome
Binary restenosis
Time frame: 9 months
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 8 Nov 2011.
- Derived from this study: PubMed 23152364Lupi A, Rognoni A, Secco GG, Lazzero M, Nardi F, Fattori R, Bongo AS, Agostoni P, Sheiban I. Biodegradable versus durable polymer drug eluting stents in coronary artery disease: insights from a meta-analysis of 5,834 patients. Eur J Prev Cardiol. 2014 Apr;21(4):411-24. doi: 10.1177/2047487312467745. Epub 2012 Nov 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
AOU Maggiore della Carita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restenosis and Myocardial Infarction, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 3 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 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
late coronary lumen loss (time frame: 9 month). The study lists 5 primary outcomes in all. 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 NCT01466634, 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 8 Nov 2011.