Coronary Bifurcation LesionsPhase 4NCT02384629
PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
A Phase 4 study testing OCT-guided PCI with AXXESS stent, OCT-guided PCI with conventional DES (Biomatrix flex stent) and Angio-guided PCI with AXXESS stent in people with Coronary Bifurcation Lesions, run by Yonsei University.
Trial summary
1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease 2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Coronary Bifurcation Lesions
- What is being tested?
- OCT-guided PCI with AXXESS stent, OCT-guided PCI with conventional DES (Biomatrix flex stent) and Angio-guided PCI with AXXESS stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2017
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures,
- Patients ≥ 19 years old,
- Patients who are expected to undergo PCI for bifurcation lesions.
Who cannot join
- Age> 85 years,
- Cardiogenic shock or unstable patients,
- Increased risk of bleeding, anemia, thrombocytopenia,
- A need for oral anticoagulation therapy,
- Pregnant women or women with potential childbearing,
- Life expectancy < 1 year.
About this study
- To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
- To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type
- Conditions
- Coronary Bifurcation Lesions
- Being tested
- OCT-guided PCI with AXXESS stent, OCT-guided PCI with conventional DES (Biomatrix flex stent), Angio-guided PCI with AXXESS stent, Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-guided PCI with AXXESS stentDevice
The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods.
OCT-guided PCI with conventional DES (Biomatrix flex stent)Device
BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods.
Angio-guided PCI with AXXESS stentDevice
The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. We use the conventional coronary angiography.
Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)Device
BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. We use the conventional coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| AXXESS stent1 | Experimental | AXXESS stent (OCT-guided) Receives: Device: OCT-guided PCI with AXXESS stent |
| Conventional DES1 | Experimental | Conventional DES (Biomatrix flex stent, OCT-guided) Receives: Device: OCT-guided PCI with conventional DES (Biomatrix flex stent) |
| AXXESS stent2 | Active comparator | AXXESS stent (Angio-guided) Receives: Device: Angio-guided PCI with AXXESS stent |
| Conventional DES2 | Active comparator | Conventional DES (Biomatrix flex stent, Angio-guided) Receives: Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late loss of side branch(SB)
Late loss was defined as the difference between the minimal luminal diameter (MLD) immediately after the procedure and the MLD at 9-month follow-up, Measured the change in MLD by Quantitative coronary angiography (QCA)
Measured: 9 months after procedure
Secondary outcomes (4)
Cardiovascular (CV) death
death for CV cause (MI, stroke)
Measured: 9 months after procedure
Myocardial infarction (MI)
MI definition: rise of cardiac biomarker with at least one of the following: Symptoms of ischemia, New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB), Development of pathological Q waves in the ECG, Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, identification of an intracoronary thrombus by angiography or autopsy
Measured: 9 months after procedure
stent thrombosis (ST)
ST definition: Academic Research Consortium (ARC) definition
Measured: 9 months after procedure
SB closure
SB closure: TIMI flow < 3 and/or stenosis >75%
Measured: 9 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Problem with medical device provider
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionsStudies 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
- 0 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
- NCT02384629
- Sponsor's protocol ID
- 1-2014-0079
- Status last verified
- Jul 2016
- First submitted
- 4 Mar 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease
- ClinicalTrials.gov ID
- NCT02384629
- Acronym / sponsor ID
- 1-2014-0079
- Conditions
- Coronary Bifurcation Lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problem with medical device provider
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Mar 2015 (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.
- To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
- To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AXXESS stent1 | Experimental | Device: OCT-guided PCI with AXXESS stentAXXESS stent (OCT-guided) |
| Conventional DES1 | Experimental | Device: OCT-guided PCI with conventional DES (Biomatrix flex stent)Conventional DES (Biomatrix flex stent, OCT-guided) |
| AXXESS stent2 | Active comparator | Device: Angio-guided PCI with AXXESS stentAXXESS stent (Angio-guided) |
| Conventional DES2 | Active comparator | Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)Conventional DES (Biomatrix flex stent, Angio-guided) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures,
- Patients ≥ 19 years old,
- Patients who are expected to undergo PCI for bifurcation lesions.
Key exclusion criteria (6 listed)
- Age> 85 years,
- Cardiogenic shock or unstable patients,
- Increased risk of bleeding, anemia, thrombocytopenia,
- A need for oral anticoagulation therapy,
- Pregnant women or women with potential childbearing,
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 |
|---|---|---|
| OCT-guided PCI with AXXESS stentThe AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods. | Device | AXXESS stent1 |
| OCT-guided PCI with conventional DES (Biomatrix flex stent)BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods. | Device | Conventional DES1 |
| Angio-guided PCI with AXXESS stentThe AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. We use the conventional coronary angiography. | Device | AXXESS stent2 |
| Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. We use the conventional coronary angiography. | Device | Conventional DES2 |
Primary outcome
Late loss of side branch(SB)
Time frame: 9 months after procedure
Late loss was defined as the difference between the minimal luminal diameter (MLD) immediately after the procedure and the MLD at 9-month follow-up, Measured the change in MLD by Quantitative coronary angiography (QCA)
4 secondary outcomes
Cardiovascular (CV) death
Time frame: 9 months after procedure
Myocardial infarction (MI)
Time frame: 9 months after procedure
stent thrombosis (ST)
Time frame: 9 months after procedure
SB closure
Time frame: 9 months after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OCT-guided PCI with AXXESS stent, OCT-guided PCI with conventional DES (Biomatrix flex stent) and Angio-guided PCI with AXXESS stent in people with Coronary Bifurcation Lesions, run by Yonsei University.
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 6 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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 loss of side branch(SB) (time frame: 9 months after procedure). 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.