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

This is an interventional treatment trial for Coronary Artery Disease Read More

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.