All-comerPhase 4NCT02084901
Comparison of Biodegradable Stents: Orsiro and BioMatrix
A Phase 4 study testing Drug-eluting biodegradable stent Orsiro implantation and Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation in people with All-comer and Percutaneous Coronary Intervention, run by Yonsei University at 1 site in South Korea.
Trial summary
The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- All-comer, Percutaneous Coronary Intervention
- What is being tested?
- Drug-eluting biodegradable stent Orsiro implantation and Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Mar 2016
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 20 years old
- Patients in the treatment of subjects with all-comer who are to undergo PCI
Who cannot join
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Seoul, 120-752
About this study
The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.
The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.
Read the detailed description
The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.
The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.
- Conditions
- All-comer, Percutaneous Coronary Intervention
- Being tested
- Drug-eluting biodegradable stent Orsiro implantation, Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
- Keywords
- Biodegradable stents, converage, OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting biodegradable stent Orsiro implantationDevice
Drug-eluting biodegradable stent Orsiro implantation
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantationDevice
Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
| Study group | Role | What they receive |
|---|---|---|
| Orsiro Arm | Experimental | Not described Receives: Device: Drug-eluting biodegradable stent Orsiro implantation |
| BioMatrix or BioMatrix Flex Arm | Active comparator | Not described Receives: Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neointimal coverage at 3 month after stent implantation
The percentage of stent uncoverage measured by optical coherence tomography
Measured: At 3 months after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All-comerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084901
- Sponsor's protocol ID
- 1-2013-0083
- Status last verified
- Jul 2016
- First submitted
- 9 Mar 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biodegradable Stents: Orsiro and BioMatrix
- ClinicalTrials.gov ID
- NCT02084901
- Acronym / sponsor ID
- 1-2013-0083
- Conditions
- All-comer, Percutaneous Coronary Intervention
- Keywords
- Biodegradable stents, converage, OCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Mar 2014 (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.
The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.
The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.
Detailed description
The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation.
The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orsiro Arm | Experimental | Device: Drug-eluting biodegradable stent Orsiro implantation |
| BioMatrix or BioMatrix Flex Arm | Active comparator | Device: Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 20 years old
- Patients in the treatment of subjects with all-comer who are to undergo PCI
Key exclusion criteria (2 listed)
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
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 biodegradable stent Orsiro implantationDrug-eluting biodegradable stent Orsiro implantation | Device | Orsiro Arm |
| Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantationDrug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation | Device | BioMatrix or BioMatrix Flex Arm |
Primary outcome
Neointimal coverage at 3 month after stent implantation
Time frame: At 3 months after stent implantation
The percentage of stent uncoverage measured by optical coherence tomography
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 27 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug-eluting biodegradable stent Orsiro implantation and Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation in people with All-comer and Percutaneous Coronary Intervention, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 2 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 27 Jul 2016. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neointimal coverage at 3 month after stent implantation (time frame: At 3 months after stent implantation). 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 27 Jul 2016.