Coronary Artery StenosisCOBRANCT00895791
COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study
A study testing AXXESS Biolimus A9-eluting bifurcation stent and culotte stenting (Xience V) in people with Coronary Artery Stenosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- AXXESS Biolimus A9-eluting bifurcation stent and culotte stenting (Xience V)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years
- Written informed consent available
- Patient eligible for percutaneous coronary intervention
- Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1))
- Target reference vessel diameter measured by QCA: 2-4 mm
- Target lesion stenosis measured by QCA: > 70% - < 100%
- Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations
Who cannot join
- Left ventricular ejection fraction of < 30%
- Impaired renal function (serum creatinine > 2.0 mg/dl)
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk > 50%, unprotected
- Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus
- Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
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- Patients with a life expectancy of less than one year
- Patient currently enrolled in other investigational device or drug trial
- Patient not able or willing to adhere to follow-up visits
- Patients who intend to have a major surgical intervention within 6 months of enrolment in the study
- Patient not able or willing to adhere to follow-up visits
- Patients who previously participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With the AXXESS Biolimus A9 Eluting Stent Versus Culotte Technique Using Everolimus-eluting Stents: an Optical Coherence Tomography Analysis.
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall.
Read the detailed description
Background: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis.
Methods: Patients with complex bifurcation lesions with involvement of a significant side branch requiring a stent are randomized into two treatment arms. The first group of 20 patients (group I) is treated with the AXXESS Biolimus A9 Bifurcation Stent System (Devax, Inc, Lake Forest CA), where additional everolimus-eluting Xience V stents (Abbott Vascular, Santa Clara, CA) are implanted into the distal main branch and the side branch as required. The second group of 20 patients (group II) is treated with the culotte technique using everolimus-eluting Xience V stents. Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography (with QCA using dedicated software) and OCT (of both main vessel and side branch) is performed.
Assessment of Results:
- EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months.
- EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis.
- Conditions
- Coronary Artery Stenosis
- Being tested
- AXXESS Biolimus A9-eluting bifurcation stent, culotte stenting (Xience V)
- Keywords
- coronary bifurcation, stent implantation, PCI, Optical Coherence Tomography
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXXESS Biolimus A9-eluting bifurcation stentDevice
implantation of stent
culotte stenting (Xience V)Device
Also called culotte stenting with Xience V
implantation of stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AXXESS Biolimus A9-eluting bifurcation stent Receives: Device: AXXESS Biolimus A9-eluting bifurcation stent |
| 2 | Active comparator | culotte stenting with use of 2 drug eluting stents Receives: Device: culotte stenting (Xience V) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up.
Measured: 9 months
Secondary outcomes (1)
Clinical outcome: Cumulative MACE rate at 1, 8, 9 and 12 months, yearly until 5 years. Separate rates will be provided for: cardiac death, non-fatal myocardial infarction, clinically driven TLR, TVR.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: major protocol changes: new study submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Adriaenssens, MD, Principal investigator, UZLeuven, cardiologyWalter Desmet, MD, PhD, Study director, UZ Leuven, Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895791
- Sponsor's protocol ID
- Eudract: 2009-010879-24
- Acronym
- COBRA
- Status last verified
- May 2009
- First submitted
- 7 May 2009
- Last updated
- 27 Jan 2023
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With the AXXESS Biolimus A9 Eluting Stent Versus Culotte Technique Using Everolimus-eluting Stents: an Optical Coherence Tomography Analysis.
- ClinicalTrials.gov ID
- NCT00895791
- Acronym / sponsor ID
- COBRA / Eudract: 2009-010879-24
- Conditions
- Coronary Artery Stenosis
- Keywords
- coronary bifurcation, stent implantation, PCI, Optical Coherence Tomography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: major protocol changes: new study submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 May 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.
The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall.
Detailed description
Background: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis.
Methods: Patients with complex bifurcation lesions with involvement of a significant side branch requiring a stent are randomized into two treatment arms. The first group of 20 patients (group I) is treated with the AXXESS Biolimus A9 Bifurcation Stent System (Devax, Inc, Lake Forest CA), where additional everolimus-eluting Xience V stents (Abbott Vascular, Santa Clara, CA) are implanted into the distal main branch and the side branch as required. The second group of 20 patients (group II) is treated with the culotte technique using everolimus-eluting Xience V stents. Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography (with QCA using dedicated software) and OCT (of both main vessel and side branch) is performed.
Assessment of Results:
- EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months.
- EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: AXXESS Biolimus A9-eluting bifurcation stentAXXESS Biolimus A9-eluting bifurcation stent |
| 2 | Active comparator | Device: culotte stenting (Xience V)culotte stenting with use of 2 drug eluting stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient older than 18 years
- Written informed consent available
- Patient eligible for percutaneous coronary intervention
- Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1))
- Target reference vessel diameter measured by QCA: 2-4 mm
Key exclusion criteria (12 listed)
- Left ventricular ejection fraction of < 30%
- Impaired renal function (serum creatinine > 2.0 mg/dl)
- Previous and/or planned brachytherapy of target vessel
- Lesion of the left main trunk > 50%, unprotected
- Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus
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 |
|---|---|---|
| AXXESS Biolimus A9-eluting bifurcation stentimplantation of stent | Device | 1 |
| culotte stenting (Xience V)Also: culotte stenting with Xience Vimplantation of stent | Device | 2 |
Primary outcome
The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up.
Time frame: 9 months
1 secondary outcome
Clinical outcome: Cumulative MACE rate at 1, 8, 9 and 12 months, yearly until 5 years. Separate rates will be provided for: cardiac death, non-fatal myocardial infarction, clinically driven TLR, TVR.
Time frame: 5 years
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 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Tom Adriaenssens, MD principal investigator
UZLeuven, cardiology
Walter Desmet, MD, PhD study director
UZ Leuven, Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXXESS Biolimus A9-eluting bifurcation stent and culotte stenting (Xience V) in people with Coronary Artery Stenosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 inclusion and 12 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 Jan 2023. 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 Belgium. 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 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?
The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up. (time frame: 9 months). 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 Jan 2023.