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

Coronary Artery Disease Clinical Trial

— COBRAII  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02628288
• Other study ID #: S-57892
• Status: Not yet recruiting
• Phase: N/A
• First received: November 17, 2015
• Last updated: December 8, 2015
• Start date: December 2015
• Est. completion date: November 2020

Study information

• Verified date: November 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Johan Bennett, MD
• Email: johan.bennett[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient older than 18 years

2. The subject has stable or unstable angina pectoris, or a positive functional study for ischemia.

3. The subject is eligible for PCI, and is an acceptable candidate for coronary artery bypass surgery.

4. 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.

5. The subject has signed the informed consent prior to the procedure, and agrees to comply with the follow up requirements.

6. 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.

7. 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).

8. The lesion must be at least 50% diameter stenosis within either the MB or SB (by visual estimate).

9. 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).

10. The side branch ostium is located at least 10 mm from the left main coronary artery (by visual estimate).

11. The angle between the sidebranch and the parent vessel is less than 70°(by visual estimate).

Exclusion Criteria:

1. Left ventricular ejection fraction of < 30%

2. Impaired renal function (serum creatinine > 2.0 mg/dl)

3. Previous and/or planned brachytherapy of target vessel

4. Known allergies to antiplatelet, anticoagulation therapy, contrast media, biolimus or everolimus, nickel, titanium or poly-D,L-lactic Acid.

5. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)

6. Patients with a life expectancy of less than three years

7. 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

8. Patient not able or willing to adhere to follow-up visits

9. Patients who intend to have a major surgical intervention within 12 months of enrolment in the study.

10. Patients who previously participated in this study.

11. 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.

12. Creatinine Kinase (CK) greater than two times URL with presence of CKMB greater than the site URL at the time of procedure.

13. 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

14. The subject has experienced a significant gastrointestinal or genitourinary bleed within the past six months, or has had any active bleeding within two months.

15. 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.

16. Planned revascularization within 1 year after index procedure.

17. The target vessel contains intraluminal thrombus.

18. The target lesion is located in the left main coronary artery

19. Lesion of the left main trunk > 50%, unprotected

20. The subject has another lesion within the target vessel parent or side branch requiring treatment besides the bifurcation lesion

21. The subject has had prior PCI to the target lesion, including a 5mm zone proximal and distal to the lesion

22. The target lesion shows angiographic evidence of severe calcification or tortuosity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Bifurcation PCI
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.

Locations

Country	Name	City	State
Belgium	Department of Cardiovascular Disease, University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 months	No
Secondary	Acute strut apposition following index PCI (baseline OCT)		30 months	No
Secondary	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.		1 month, 6 months, 1,2,3,4,5 years	No
Secondary	Quantitative coronary angiography (QCA) Minimal Lumen Diameter before and after PCI, and at 30 months		24 hours and at 30 months	No
Secondary	Device success, defined as deployment of the assigned stents without system failure or device-related complication		24 hours	No
Secondary	Presence of thrombus on final OCT pullback following index PCI		24 hours	No
Secondary	- Assessment of the integrity of the Absorb BVS following completion of index PCI using 3D OCT.		24 hours	No
Secondary	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)		24 hours and 30 months	No
Secondary	Changes in minimal luminal area in all 10 pre-specified bifurcation segments, assessed with OCT, from baseline to 30 months.		24 hours and 30 months	No
Secondary	Percent struts malapposed in the Axxess stent at 30 months post procedure		30 months	No
Secondary	Percent struts uncovered in the Axxess stent at 30 months post procedure		30 months	No
Secondary	Target vessel failure (TVF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR)		1 month, 6 months, 1,2,3,4,5 years	No
Secondary	Stent thrombosis at 24h, 1 month, 12 months and yearly thereafter (up to 5y)		1 month, 6 months, 1,2,3,4,5 years	No
Secondary	Target lesion revascularisation (TLR) at 1, 6, 12 months and yearly thereafter (up to 5y)		1 month, 6 months, 1,2,3,4,5 years	No
Secondary	Target vessel revascularisation (TVR) at at 1, 6, 12 months and yearly thereafter (up to 5y)		1 month, 6 months, 1,2,3,4,5 years	No
Secondary	All-cause death, cardiac death, non-TVR, any revascularization at 1, 6, 12 months and yearly thereafter (up to 5y)		1 month, 6 months, 1,2,3,4,5 years	No
Secondary	Acute gain following index PCI		24 hours	No
Secondary	Late Lumen Loss (in-stent) at 30 months		30 months	No
Secondary	Binary in-stent/scaffold restenosis at 30 months		30 months	No
Secondary	Binary in-segment restenosis at 30 months		30 months	No
Secondary	Binary in-bifurcation restenosis (stent and segment) at 30 months		30 months	No
Secondary	Lesion success, defined as attainment of <50% residual stenosis of the target lesion using any percutaneous method		24 hours	No
Secondary	Procedure success, defined as lesion success without the occurrence of MACE during the hospital stay.		24 hours	No
Secondary	Analysis of the vasoreactivity (Vasomotor testing, using vasodilatory response to acetylcholine (Ach) in all patients) of the bifurcation segments previously stented/scaffolded.		30 months	No
Secondary	Procedure duration from randomization to final angiogram (before final OCT)		24 hours	No
Secondary	Contrast usage from randomization to final angiogram (before final OCT)		24 hours	No
Secondary	Radiation from randomization to final angiogram (before final OCT)		24 hours	No