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The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries (BIOADAPTOR RCT)

Primary Purpose

Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Sponsored by
Elixir Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Ste, Bioadaptor, Percutaneous Coronary Intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

General Inclusion Criteria

Patients who meet all of the following criteria are eligible:

  1. Patient must be ≥ 20 years of age.
  2. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
  3. Patients who are able to take dual anti-platelet therapy for 1 year following the index procedure and anticoagulants prior to/during the index procedure.
  4. The subject is an acceptable candidate for Percutaneous Transluminal Coronary Angioplasty (PTCA), stenting, and emergent Coronary Artery Bypass Graft (CABG) surgery.
  5. The subject or subject's legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board or Ethics Committee of the respective clinical site.
  6. Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing
  7. Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing
  8. Patient must agree not to participate in any other clinical research study for a period of one year following the index procedure
  9. Target lesion(s) must be de novo and located in a native coronary artery with a vessel mean diameter of ≥ 2.25 and ≤ 4.0 mm.
  10. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of > 1. When two target lesions are treated, they must be located in separate major epicardial vessels
  11. visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 14/15/18/23/28/32/38 mm ELX1805J stent and have at least 2 mm of healthy vessel on either side Or
  12. The visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 15/18/22/30/34/38 mm ZES stent respectively and have at least 2 mm of healthy vessel on either side.
  13. The lesion(s) must be successfully pre-dilated prior to enrollment Mandatory pre-dilatation includes the use of 2 orthogonal views to confirm lesion inclusion and exclusion criteria and successful pre-dilatation defined as balloon inflation without waist and a lumen diameter no less than 0.5 mm smaller than the vessel diameter.
  14. Percutaneous intervention of lesions in a non-target vessel if:

    • Not part of a another clinical investigation
    • ≥ 30 days prior to the study index procedure
    • ≥ 6 months after the study index procedure (planned)
  15. Percutaneous intervention of lesions located in the target vessel if:

    • Not part of a clinical investigation
    • ≥ 6 months prior to the study index procedure
    • >12 months after the study index procedure (planned)
    • Previous intervention was distal to and >10 mm from the target lesion

Exclusion Criteria:

  1. The patient was diagnosed with an acute myocardial infarction within the past 72 hours and the CK and CKMB have not returned to normal (or cTn >15x ULN) and the patient is experiencing clinical symptoms indicative of ongoing ischemia
  2. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, cobalt, nickel, chromium, molybdenum, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
  3. Patients with a history of allergic reaction or serious hypersensitivity to drugs exhibiting interactions with sirolimus, zotarolimus, everolimus, tacrolimus, temsirolimus, biolimus and other rapamycin, derivatives or analogues) or similar drugs
  4. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.
  5. Patient presenting with chronic (permanent) atrial or ventricular arrhythmia or current unstable ventricular arrhythmias
  6. Patient has a known left ventricular ejection fraction (LVEF) < 30%
  7. Patient has received a heart or other organ transplant or is on a waiting list for any organ transplant
  8. Patient has a malignancy that is not in remission.
  9. Patient is receiving immunosuppression therapy other than steroids and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  10. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
  11. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected to have cirrhosis of Child-Pugh ≥ Class B within 7 days before study procedure
  12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL within 7 days before study procedure, or patient on dialysis)
  13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  15. Patient has had a significant GI or urinary bleed within the past six months
  16. Patient has severe symptomatic heart failure (i.e., NYHA class IV)
  17. Patient has a medical condition that precludes safe 6 French sheath insertion
  18. Patient has other medical illness or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
  19. Patient is already participating in another clinical research study which has not reached the primary endpoint (long-term follow-up is not an exclusion)
  20. Other patients whom primary investigator or subinvestigator determined to be ineligible for this clinical study
  21. Patients with bypass graft to the target vessel or lesion is located in a bypass graft
  22. Patients with stent implanted within 10 mm of proximal or distal end of target lesion
  23. Patients with a target lesion involving a bifurcation of which the side branch will be jailed by the struts and:

    • Side branch ≥ 2.5 mm in diameter,
    • Side branch requiring predilatation (including Kissing Balloon Technique), or
    • Side branch has an ostial lesion or lesion with > 50% stenosis
  24. Patients suspected or confirmed with the QCA analysis of having stenotic lesion of more than 50% in target vessel in addition to target lesion
  25. Patients with target lesion in ostia located within 5 mm of origin of LAD, LCX or RCA
  26. Patients with stenotic lesion in left main trunk
  27. Patients with target lesion that is a chronic total occlusion (CTO) or ≤ TIMI 1 coronary flow in the target vessel
  28. Patients with target vessel that contains thrombus as indicated in pre-procedure angiographic, IVUS or OCT images
  29. Excessive tortuosity ≥ two 45° angles or extreme angulation (≥ 90°) proximal to or within the target lesion
  30. Patients with target vessel that has moderate to severe calcification that prevents complete angioplasty balloon (POBA with non-compliant balloon, or scoring balloon,) inflation or requires other devices such as rotational atherectomy, rotoblator.
  31. Patients with dissection of Grade A or B that cannot be covered (including 2mm distal to the dissection) with a single study device or with dissection of Grade C or higher
  32. Patients with 2 or more target lesions on 1 branch or target lesions on 3 branches that need to be treated during study procedure
  33. Target lesion involves a myocardial bridge

Sites / Locations

  • AZ Middelheim Hospital
  • AZ Sint Jan Brugge
  • Ziekenhuis Oost-Limburg
  • Universitaire Ziekenhuizen Leuven
  • Kerkhoff Klinik GmbH
  • Segeberger Kliniken GmbH
  • REGIOMED Klinikum Coburg
  • St. Johannes Hospital
  • Universitatsklinikum Erlangen
  • Elisabeth Krankenhaus Essen
  • MVZ CCB Frankfurt
  • Universitatsklinikun Giessen
  • Universitätsklinikum Jena
  • UKSH Kiel Klinik
  • Universitätsmedizin-Mainz
  • Krankenhaus der barmherzigen Bruder
  • Kokura Memorial Hospital
  • Shinkoga Hospital
  • Sapporo Higashi Tokushukai Hospital
  • Takahashi Hospital
  • Tsuchiura Kyodo Hospital
  • Tenyokai Central Hospital
  • Shonan Kamakura General Hospital
  • Kanto Rosai Hospital
  • Yokohama City Eastern Hospital
  • Kumamoto Rousai Hospital
  • Miyazaki Medical Association Hospital
  • Oumi Hachiman City General Medical Center
  • Cardiovascular Reaearch Institute
  • Teikyo University Hospital
  • Auckland City Hospital
  • Middlemore Clinical Trials Trust
  • Waikato Hospital
  • Christchurch Hospital
  • Dunedin Hospital
  • North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elixir Bioadaptor (ELX1805J)

Medtronic Resolute Onyx Stent

Arm Description

The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length

The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length

Outcomes

Primary Outcome Measures

Number of Patients with Target Lesion Failure (TLF)
TLF is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated

Secondary Outcome Measures

Number of Patients with Target Lesion Failure (TLF)
TLF is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated
Number of Patients with Patient Oriented Clinical Endpoint
Overall cardiovascular outcomes from the patient's perspective. This endpoint is a composite endpoint that includes all-cause mortality (cardiac and non-cardiac), stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)
Number of Patients with Composite of All-cause mortality
A composite of all-cause mortality, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)
Number of Patients with Composite of Cardiac Death TVMI and ID-TVR revascularization
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR)
Number of Patients with Cardiac death, stroke, MI and revascularization
Composite of cardiac death, stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)
Number of Patients with Cardiac death, MI and revascularization
Composite of cardiac death, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)
Number of Patients with Ischemia Driven Target Lesion Revascularization (ID-TLR)
Ischemia driven target lesion revascularization
Number of Patients with Target Lesion Revascularization (TLR)
Target lesion revascularization
Number of Patients with Target Vessel Revascularization (TVR)
Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications
Number of Patients with Ischemia driven TVR (ID-TVR)
Re-PCI or CABG in the target vessel due to restenosis or other complications
Number of Patients with Revascularization (target vessel or non-target vessel)
Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications
Number of Patients with Q-wave MI
CK post procedure is twice the upper limit of the reference value or higher, with new pathological Q-wave on 2 or more contiguous ECG leads and if CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.
Number of Patients with Non Q-wave MI
CK post procedure is twice the upper limit of the reference value or higher, without new pathological Q-waves. If CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.
Number of Patients with MI (target vessel or non-target vessel)
per ARC II
Number of Patients with Target Vessel MI
per ARC II
Number of Patients with All-cause Death
Per ARC II Definitions
Number of Patients with Cardiac Death
Per ARC II Definitions
Number of Patients with Composite of Cardiac Death or Target Vessel MI
Target Vessel Related Death or MI
Number of Patients with Composite of all-cause Death or MI
target vessel or non-target vessel related death or MI
Number of Patients with Composite of all-cause Death, MI (target vessel or non-target vessel), or TVR
Any Death, any MI and any Target Vessel Revascularization
Number of Patients with Composite of Probable or Definite Stent Thrombosis
Per ARC II Definitions
Number of Patients with Probable Stent Thrombosis
Per ARC II Definitions
Number of Patients with Definite Stent Thrombosis
Per ARC II Definitions

Full Information

First Posted
December 6, 2019
Last Updated
September 5, 2023
Sponsor
Elixir Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04192747
Brief Title
The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries
Acronym
BIOADAPTOR RCT
Official Title
Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elixir Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions
Detailed Description
The Bioadaptor RCT Study is a prospective, 1:1 randomized study of parallel designed, that will enroll up to 444 patients requiring treatment of up to two de novo coronary lesions of ≤ 34 mm in length in vessels of ≥ 2.25 mm and ≤ 4.0 mm in diameter. One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or LAD), and meeting the inclusion/exclusion criteria may be treated with the ELX1805J (DynamX Bioadaptor) or Resolute Onyx stent The primary safety endpoint is Target Lesion Failure (TLF) at 12 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and 12 months and 2-5 years. Using visual assessment, the target lesion must measure ≥ 2.25 mm and ≤ 4.0 mm in diameter and ≤ 34 mm in length able to be covered by a single ELX1805J or Resolute Onyx stent including 2 mm of healthy vessel on either side of the planned treatment area. The patient will be eligible for device implantation only after satisfactory lesion pre-dilatation defined as: ≥ TIMI 2 flow, and no dissection greater than Grade B (NHLBI) able to be covered with a single device

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
Keywords
Coronary Ste, Bioadaptor, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, 1:1 Randomized trial of parallel design
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elixir Bioadaptor (ELX1805J)
Arm Type
Experimental
Arm Description
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Arm Title
Medtronic Resolute Onyx Stent
Arm Type
Active Comparator
Arm Description
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
Percutaneous coronary intervention of de novo native coronary artery lesions
Primary Outcome Measure Information:
Title
Number of Patients with Target Lesion Failure (TLF)
Description
TLF is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Number of Patients with Target Lesion Failure (TLF)
Description
TLF is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated
Time Frame
30 Days, 180 Days, 2, 3, 4 and 5 years
Title
Number of Patients with Patient Oriented Clinical Endpoint
Description
Overall cardiovascular outcomes from the patient's perspective. This endpoint is a composite endpoint that includes all-cause mortality (cardiac and non-cardiac), stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Composite of All-cause mortality
Description
A composite of all-cause mortality, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Composite of Cardiac Death TVMI and ID-TVR revascularization
Description
Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR)
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Cardiac death, stroke, MI and revascularization
Description
Composite of cardiac death, stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Cardiac death, MI and revascularization
Description
Composite of cardiac death, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Ischemia Driven Target Lesion Revascularization (ID-TLR)
Description
Ischemia driven target lesion revascularization
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Target Lesion Revascularization (TLR)
Description
Target lesion revascularization
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Target Vessel Revascularization (TVR)
Description
Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Ischemia driven TVR (ID-TVR)
Description
Re-PCI or CABG in the target vessel due to restenosis or other complications
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Revascularization (target vessel or non-target vessel)
Description
Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Q-wave MI
Description
CK post procedure is twice the upper limit of the reference value or higher, with new pathological Q-wave on 2 or more contiguous ECG leads and if CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Non Q-wave MI
Description
CK post procedure is twice the upper limit of the reference value or higher, without new pathological Q-waves. If CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with MI (target vessel or non-target vessel)
Description
per ARC II
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Target Vessel MI
Description
per ARC II
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with All-cause Death
Description
Per ARC II Definitions
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Cardiac Death
Description
Per ARC II Definitions
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Composite of Cardiac Death or Target Vessel MI
Description
Target Vessel Related Death or MI
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Composite of all-cause Death or MI
Description
target vessel or non-target vessel related death or MI
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Composite of all-cause Death, MI (target vessel or non-target vessel), or TVR
Description
Any Death, any MI and any Target Vessel Revascularization
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Composite of Probable or Definite Stent Thrombosis
Description
Per ARC II Definitions
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Probable Stent Thrombosis
Description
Per ARC II Definitions
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years
Title
Number of Patients with Definite Stent Thrombosis
Description
Per ARC II Definitions
Time Frame
30 Days, 180 Days, 1, 2, 3, 4 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: General Inclusion Criteria Patients who meet all of the following criteria are eligible: Patient must be ≥ 20 years of age. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia) Patients who are able to take dual anti-platelet therapy for 1 year following the index procedure and anticoagulants prior to/during the index procedure. The subject is an acceptable candidate for Percutaneous Transluminal Coronary Angioplasty (PTCA), stenting, and emergent Coronary Artery Bypass Graft (CABG) surgery. The subject or subject's legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board or Ethics Committee of the respective clinical site. Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing Patient must agree not to participate in any other clinical research study for a period of one year following the index procedure Target lesion(s) must be de novo and located in a native coronary artery with a vessel mean diameter of ≥ 2.25 and ≤ 4.0 mm. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of > 1. When two target lesions are treated, they must be located in separate major epicardial vessels visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 14/15/18/23/28/32/38 mm ELX1805J stent and have at least 2 mm of healthy vessel on either side Or The visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 15/18/22/30/34/38 mm ZES stent respectively and have at least 2 mm of healthy vessel on either side. The lesion(s) must be successfully pre-dilated prior to enrollment Mandatory pre-dilatation includes the use of 2 orthogonal views to confirm lesion inclusion and exclusion criteria and successful pre-dilatation defined as balloon inflation without waist and a lumen diameter no less than 0.5 mm smaller than the vessel diameter. Percutaneous intervention of lesions in a non-target vessel if: Not part of a another clinical investigation ≥ 30 days prior to the study index procedure ≥ 6 months after the study index procedure (planned) Percutaneous intervention of lesions located in the target vessel if: Not part of a clinical investigation ≥ 6 months prior to the study index procedure >12 months after the study index procedure (planned) Previous intervention was distal to and >10 mm from the target lesion Exclusion Criteria: The patient was diagnosed with an acute myocardial infarction within the past 72 hours and the CK and CKMB have not returned to normal (or cTn >15x ULN) and the patient is experiencing clinical symptoms indicative of ongoing ischemia Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, cobalt, nickel, chromium, molybdenum, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated Patients with a history of allergic reaction or serious hypersensitivity to drugs exhibiting interactions with sirolimus, zotarolimus, everolimus, tacrolimus, temsirolimus, biolimus and other rapamycin, derivatives or analogues) or similar drugs Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors. Patient presenting with chronic (permanent) atrial or ventricular arrhythmia or current unstable ventricular arrhythmias Patient has a known left ventricular ejection fraction (LVEF) < 30% Patient has received a heart or other organ transplant or is on a waiting list for any organ transplant Patient has a malignancy that is not in remission. Patient is receiving immunosuppression therapy other than steroids and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected to have cirrhosis of Child-Pugh ≥ Class B within 7 days before study procedure Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL within 7 days before study procedure, or patient on dialysis) Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months Patient has had a significant GI or urinary bleed within the past six months Patient has severe symptomatic heart failure (i.e., NYHA class IV) Patient has a medical condition that precludes safe 6 French sheath insertion Patient has other medical illness or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) Patient is already participating in another clinical research study which has not reached the primary endpoint (long-term follow-up is not an exclusion) Other patients whom primary investigator or subinvestigator determined to be ineligible for this clinical study Patients with bypass graft to the target vessel or lesion is located in a bypass graft Patients with stent implanted within 10 mm of proximal or distal end of target lesion Patients with a target lesion involving a bifurcation of which the side branch will be jailed by the struts and: Side branch ≥ 2.5 mm in diameter, Side branch requiring predilatation (including Kissing Balloon Technique), or Side branch has an ostial lesion or lesion with > 50% stenosis Patients suspected or confirmed with the QCA analysis of having stenotic lesion of more than 50% in target vessel in addition to target lesion Patients with target lesion in ostia located within 5 mm of origin of LAD, LCX or RCA Patients with stenotic lesion in left main trunk Patients with target lesion that is a chronic total occlusion (CTO) or ≤ TIMI 1 coronary flow in the target vessel Patients with target vessel that contains thrombus as indicated in pre-procedure angiographic, IVUS or OCT images Excessive tortuosity ≥ two 45° angles or extreme angulation (≥ 90°) proximal to or within the target lesion Patients with target vessel that has moderate to severe calcification that prevents complete angioplasty balloon (POBA with non-compliant balloon, or scoring balloon,) inflation or requires other devices such as rotational atherectomy, rotoblator. Patients with dissection of Grade A or B that cannot be covered (including 2mm distal to the dissection) with a single study device or with dissection of Grade C or higher Patients with 2 or more target lesions on 1 branch or target lesions on 3 branches that need to be treated during study procedure Target lesion involves a myocardial bridge
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Chief Director, Shonan Kamakura General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Middelheim Hospital
City
Antwerp
Country
Belgium
Facility Name
AZ Sint Jan Brugge
City
Brugge
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
Country
Belgium
Facility Name
Kerkhoff Klinik GmbH
City
Bad Nauheim
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
Country
Germany
Facility Name
REGIOMED Klinikum Coburg
City
Coburg
Country
Germany
Facility Name
St. Johannes Hospital
City
Dortmund
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Elisabeth Krankenhaus Essen
City
Essen
Country
Germany
Facility Name
MVZ CCB Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Universitatsklinikun Giessen
City
Giessen
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Facility Name
UKSH Kiel Klinik
City
Kiel
Country
Germany
Facility Name
Universitätsmedizin-Mainz
City
Mainz
Country
Germany
Facility Name
Krankenhaus der barmherzigen Bruder
City
Trier
Country
Germany
Facility Name
Kokura Memorial Hospital
City
Kitakyushu City
State/Province
Fukuoka-Ken
Country
Japan
Facility Name
Shinkoga Hospital
City
Kurume City
State/Province
Fukuoka-Ken
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Takahashi Hospital
City
Tsuchiura City
State/Province
Ibaraki-Ken
Country
Japan
Facility Name
Tsuchiura Kyodo Hospital
City
Tsuchiura City
State/Province
Ibaraki-Ken
Country
Japan
Facility Name
Tenyokai Central Hospital
City
Kagoshima City
State/Province
Kagoshima-Ken
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura City,
State/Province
Kanagawa-Ken
Country
Japan
Facility Name
Kanto Rosai Hospital
City
Kawasaki-shi
State/Province
Kanagawa-Ken
Country
Japan
Facility Name
Yokohama City Eastern Hospital
City
Yokohama-shi
State/Province
Kanagawa-Ken
Country
Japan
Facility Name
Kumamoto Rousai Hospital
City
Kumamoto
State/Province
Kumamoto-Ken
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki City
State/Province
Miyazaki-Ken
Country
Japan
Facility Name
Oumi Hachiman City General Medical Center
City
Hachiman
State/Province
Shiga-Ken
Country
Japan
Facility Name
Cardiovascular Reaearch Institute
City
Tokyo
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
Country
Japan
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Middlemore Clinical Trials Trust
City
Auckland
Country
New Zealand
Facility Name
Waikato Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
North Shore Hospital
City
Takapuna
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

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