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Coronary Artery DiseaseCOBRAIINCT02628288

COmplex Bifurcation PCI: AXXESS Device + Absorb BVS, vs Modified T Stenting With Absorb BVS

A study testing Coronary Bifurcation PCI in people with Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Comparison of healing responses after treatment of complex bifurcation lesions with a dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System + Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb BVS: an optical coherence tomography (OCT) analysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coronary Bifurcation PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
Dec 2015to Nov 2020
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
  • The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.
  • The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery.
  • The subject is male, or if female, has no childbearing potential or has had a negative urine or serum pregnancy test within 7 days of the index procedure and has no intention to become pregnant within a year of the procedure.
  • The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements.
  • Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)) or any other anatomical presentation requiring a double stent technique by judgment of the operator.
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  • Coronary artery with proximal parent vessel reference diameter of 2.75 - 3.75 mm and a branch vessel diameter of ≥ 2.25 mm (by visual estimate).
  • The lesion must be at least 50% diameter stenosis within either the MB or SB (by visual estimate).
  • Regarding lesion length: lesion should be able to be covered by 2 Absorb BVS in a Modified T-stenting technique, or by a combination of maximally 1 AXXESS and 2 Absorb BVS (by visual estimate).
  • The side branch ostium is located at least 10 mm from the left main coronary artery (by visual estimate).
  • The angle between the sidebranch and the parent vessel is less than 70°(by visual estimate).

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
  • Known allergies to antiplatelet, anticoagulation therapy, contrast media, biolimus or everolimus, nickel, titanium or poly-D,L-lactic Acid.
  • Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
  • Patients with a life expectancy of less than three years
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  • Patient currently enrolled in other investigational device or drug trial of which the primary endpoint timing has not been reached and potentially interferes with the outcome of either of both trials
  • Patient not able or willing to adhere to follow-up visits
  • Patients who intend to have a major surgical intervention within 12 months of enrolment in the study.
  • Patients who previously participated in this study.
  • Subject has experienced an acute myocardial infarction 72 hours prior to the index procedure, as defined either by the presence of a new Q-wave in 2 or more contiguous leads, or by a CK greater than two times site upper reference limit (URL) with presence of creatine Kinase-MB ( CKMB) greater than the site URL.
  • Creatinine Kinase (CK) greater than two times URL with presence of CKMB greater than the site URL at the time of procedure.
  • The subject has suffered a stroke or transient ischemic neurological attack or cerebrovascular accident within the past six months, or has any known intracranial mass, arteriovenous malformation, aneurysm or other intracranial pathology
  • The subject has experienced a significant gastrointestinal or genitourinary bleed within the past six months, or has had any active bleeding within two months.
  • The subject is taking warfarin or NOAC, will need to take warfarin or novel oral anticoagulants (NOAC) post procedure, or has an international normalised ratio (INR) > 1.4.
  • Planned revascularization within 1 year after index procedure.
  • The target vessel contains intraluminal thrombus.
  • The target lesion is located in the left main coronary artery
  • Lesion of the left main trunk > 50%, unprotected
  • The subject has another lesion within the target vessel parent or side branch requiring treatment besides the bifurcation lesion
  • The subject has had prior PCI to the target lesion, including a 5mm zone proximal and distal to the lesion
  • The target lesion shows angiographic evidence of severe calcification or tortuosity.

Trial locations and contacts

1 site in 1 country.

Johan Bennett, MD contact

johan.bennett@uzleuven.be

Christophe Dubois, MD PhD contact

Belgium1 site

  • Department of Cardiovascular Disease, University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: COmplex Bifurcation Lesions: a RAndomized Comparison Between the AXXESS Device in Combination With Absorb BVS, and Modified T Stenting With Absorb BVS: an OCT Study.

Comparison of healing responses after treatment of complex bifurcation lesions with a dedicated bifurcation device (Axxess™ Biolimus Eluting Coronary Bifurcation Stent System + Absorb BVS in the distal branches) versus the Modified T stenting technique using Absorb BVS: an optical coherence tomography (OCT) analysis.

Read the detailed description

This is a prospective single center randomized clinical trial with baseline OCT and clinical, angiographic and OCT follow-up at thirty months. Patients with true and complex coronary bifurcation lesions are randomly assigned to treatment with the dedicated Axxess biolimus-eluting bifurcation stent in the proximal main vessel (MV) and additional Absorb everolimus-eluting BVS in the branches versus a modified T technique using Absorb BVS only. The primary endpoint is changes in minimal luminal area assessed with OCT from baseline to 30 months in pre-specified bifurcation segments. The main aims are to assess acute performance and to compare long-term vessel healing with optical coherence tomography, and clinical and angiographic outcome after treatment of complex bifurcation lesions with a dedicated stent with additional Absorb Bioabsorbable scaffolds (BVS) versus a modified T stenting technique with Absorb BVS.

Being tested
Coronary Bifurcation PCI
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Bifurcation PCIDevice

    In one group, the coronary bifurcation lesion will be treated (Coronary bifurcation PCI) with the Axxess device + Absorb BVS. In the other group, the coronary bifurcation lesions will be treated(Coronary bifurcation PCI) by modified T stenting using Absorb BVS.

Study groups in NCT02628288
Study groupRoleWhat they receive
PCI with Axxess device + AbsorB BVSActive comparatorBifurcation lesion will be treated percutaneously by performing coronary stenting with AXXESS device and additional Absorb BVS.
Receives: Device: Coronary Bifurcation PCI
PCI with Modified T with Absorb BVSActive comparatorBifurcation lesion will be treated percutaneously by performing coronary stenting with a modified T stenting technique using Absorb BVS.
Receives: Device: Coronary Bifurcation PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in minimal luminal area in 4 pre-specified bifurcation segments (Proximal mainbranch (MB) segment; Bifurcation segment; Ostial distal MB segment; Ostial side-branch (SB segment), assessed with OCT, from baseline to 30 months.

    Measured: 30 months

Secondary outcomes (26)

  1. Acute strut apposition following index PCI (baseline OCT)

    Measured: 30 months

  2. Cumulative major adverse cardiac events (MACE) rate (cardiac death, myocardial infarction, clinically driven TLR) at 1, 6 and 12 months and annually for 5 years from the procedure date.

    Measured: 1 month, 6 months, 1,2,3,4,5 years

  3. Quantitative coronary angiography (QCA) Minimal Lumen Diameter before and after PCI, and at 30 months

    Measured: 24 hours and at 30 months

  4. Device success, defined as deployment of the assigned stents without system failure or device-related complication

    Measured: 24 hours

  5. Presence of thrombus on final OCT pullback following index PCI

    Measured: 24 hours

  6. - Assessment of the integrity of the Absorb BVS following completion of index PCI using 3D OCT.

    Measured: 24 hours

  7. Minimal lumen area at baseline and follow-up in the other 6 pre-specified bifurcation segments (Proximal edge segment; Proximal MB segment; Distal MB segment; Distal MB edge segment; SB segment: Distal SB edge segment)

    Measured: 24 hours and 30 months

  8. Changes in minimal luminal area in all 10 pre-specified bifurcation segments, assessed with OCT, from baseline to 30 months.

    Measured: 24 hours and 30 months

  9. Percent struts malapposed in the Axxess stent at 30 months post procedure

    Measured: 30 months

  10. Percent struts uncovered in the Axxess stent at 30 months post procedure

    Measured: 30 months

  11. Target vessel failure (TVF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR)

    Measured: 1 month, 6 months, 1,2,3,4,5 years

  12. Stent thrombosis at 24h, 1 month, 12 months and yearly thereafter (up to 5y)

    Measured: 1 month, 6 months, 1,2,3,4,5 years

  13. Target lesion revascularisation (TLR) at 1, 6, 12 months and yearly thereafter (up to 5y)

    Measured: 1 month, 6 months, 1,2,3,4,5 years

  14. Target vessel revascularisation (TVR) at at 1, 6, 12 months and yearly thereafter (up to 5y)

    Measured: 1 month, 6 months, 1,2,3,4,5 years

  15. All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 months and yearly thereafter (up to 5y)

    Measured: 1 month, 6 months, 1,2,3,4,5 years

  16. Acute gain following index PCI

    Measured: 24 hours

  17. Late Lumen Loss (in-stent) at 30 months

    Measured: 30 months

  18. Binary in-stent/scaffold restenosis at 30 months

    Measured: 30 months

  19. Binary in-segment restenosis at 30 months

    Measured: 30 months

  20. Binary in-bifurcation restenosis (stent and segment) at 30 months

    Measured: 30 months

  21. Lesion success, defined as attainment of <50% residual stenosis of the target lesion using any percutaneous method

    Measured: 24 hours

  22. Procedure success, defined as lesion success without the occurrence of MACE during the hospital stay.

    Measured: 24 hours

  23. Analysis of the vasoreactivity (Vasomotor testing, using vasodilatory response to acetylcholine (Ach) in all patients) of the bifurcation segments previously stented/scaffolded.

    Measured: 30 months

  24. Procedure duration from randomization to final angiogram (before final OCT)

    Measured: 24 hours

  25. Contrast usage from randomization to final angiogram (before final OCT)

    Measured: 24 hours

  26. Radiation from randomization to final angiogram (before final OCT)

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2020 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02628288
Sponsor's protocol ID
S-57892
Acronym
COBRAII
Status last verified
Nov 2015
First submitted
17 Nov 2015
Last updated
11 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Bifurcation PCI in people with Coronary Artery Disease, 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 11 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 11 Dec 2015. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johan Bennett, MD (johan.bennett@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in minimal luminal area in 4 pre-specified bifurcation segments (Proximal mainbranch (MB) segment; Bifurcation segment; Ostial distal MB segment; Ostial side-branch (SB segment), assessed with OCT, from baseline to 30 months. (time frame: 30 months). 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 NCT02628288.

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 11 Dec 2015.

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COBRAII Clinical Trial NCT02628288 | AzTrials