Percutaneous Coronary InterventionRUDI 2DNCT02854423
Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients
An observational study of Percutaneous Coronary Intervention and Diabetes Mellitus, run by University of Roma La Sapienza.
Trial summary
Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Diabetes Mellitus
- What is being tested?
- percutaneous coronary interventions
- Type of treatment
- Medical device
- How many people
- 1,347 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2016
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive diabetic patients with coronary artery diseases undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation between January 2007 and May 2012
Who may be able to join
- age > 18 years
- diabetes mellitus
- percutaneous coronary interventions with biolimus eluting stent or everolimus eluting stent implantation
- signed informed consent
Who cannot join
- planned procedure requiring antiplatelet therapy withdrawal within 12 months from index coronary angioplasty
- patients with contraindication to dual antiplatelet therapy (aspirin plus ticlopidine or clopidogrel)
- known allergy to stent drugs
About this study
Official title: Long-term Comparison of Biodegradable Polymer Biolimus-eluting Stents and Durable-polymer Everolimus-eluting Stents in Patients With Diabetes Mellitus
Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. BP-BES with DP-EES have been directly compared in 2 randomized trials, showing no differences between the two devices in all-comer patients during long-term follow-up. It is unknown whether these results are consistent in real-world patients with diabetes mellitus during long-term follow-up. To evaluate the safety and efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes mellitus during long-term follow-up.
Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation were included in a multicenter registry between January 2007 and May 2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR). Secondary endpoints are the individual components of the primary endpoint as well as definite stent thrombosis (ST).
- Being tested
- percutaneous coronary interventions
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionsDevice
Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| biodegradable polymer | Not described Receives: Device: percutaneous coronary interventions | |
| durable-polymer | Not described Receives: Device: percutaneous coronary interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardiac adverse events
a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR)
Measured: 4 years
Secondary outcomes (4)
rate of definite stent thrombosis in revascularized patients according with ARC definition
Measured: 4 years
Rate of composite of all-cause death in all participants
Measured: 4 years
Rate of myocardial infarction according with definition of MI type 1in all participants
Measured: 4 years
Rate of target-vessel revascularization (TVR) in all participants
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2007
- Primary completionMay 2012
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,347 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Sardella, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854423
- Sponsor's protocol ID
- RUDI 2D
- Acronym
- RUDI 2D
- Status last verified
- Jul 2016
- First submitted
- 1 Feb 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Comparison of Biodegradable Polymer Biolimus-eluting Stents and Durable-polymer Everolimus-eluting Stents in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02854423
- Acronym / sponsor ID
- RUDI 2D / RUDI 2D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,347 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2012 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Aug 2016 (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.
Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. BP-BES with DP-EES have been directly compared in 2 randomized trials, showing no differences between the two devices in all-comer patients during long-term follow-up. It is unknown whether these results are consistent in real-world patients with diabetes mellitus during long-term follow-up. To evaluate the safety and efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes mellitus during long-term follow-up.
Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation were included in a multicenter registry between January 2007 and May 2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR). Secondary endpoints are the individual components of the primary endpoint as well as definite stent thrombosis (ST).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biodegradable polymer | – | Device: percutaneous coronary interventions |
| durable-polymer | – | Device: percutaneous coronary interventions |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive diabetic patients with coronary artery diseases undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation between January 2007 and May 2012
Key inclusion criteria (4 listed)
- age > 18 years
- diabetes mellitus
- percutaneous coronary interventions with biolimus eluting stent or everolimus eluting stent implantation
- signed informed consent
Key exclusion criteria (3 listed)
- planned procedure requiring antiplatelet therapy withdrawal within 12 months from index coronary angioplasty
- patients with contraindication to dual antiplatelet therapy (aspirin plus ticlopidine or clopidogrel)
- known allergy to stent drugs
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 interventionsConsecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation | Device | biodegradable polymer, durable-polymer |
Primary outcome
major cardiac adverse events
Time frame: 4 years
a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR)
4 secondary outcomes
rate of definite stent thrombosis in revascularized patients according with ARC definition
Time frame: 4 years
Rate of composite of all-cause death in all participants
Time frame: 4 years
Rate of myocardial infarction according with definition of MI type 1in all participants
Time frame: 4 years
Rate of target-vessel revascularization (TVR) in all participants
Time frame: 4 years
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 3 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention and Diabetes Mellitus, run by University of Roma La Sapienza.
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 4 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 3 Aug 2016. 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?
major cardiac adverse events (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2016.