COmplex Bifurcation PCI: AXXESS Device + Absorb BVS, vs Modified T Stenting With Absorb BVS
NCT ID: NCT02628288
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-12-31
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCI with Axxess device + AbsorB BVS
Bifurcation lesion will be treated percutaneously by performing coronary stenting with AXXESS device and additional Absorb BVS.
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.
PCI with Modified T with Absorb BVS
Bifurcation lesion will be treated percutaneously by performing coronary stenting with a modified T stenting technique using Absorb BVS.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Johan Bennett, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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Department of Cardiovascular Disease, University Hospitals Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Christophe Dubois, MD PhD
Role: CONTACT
Other Identifiers
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S-57892
Identifier Type: -
Identifier Source: org_study_id