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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04192747




Registration number
NCT04192747
Ethics application status
Date submitted
6/12/2019
Date registered
10/12/2019
Date last updated
22/10/2024

Titles & IDs
Public title
The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries
Scientific title
Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805
Secondary ID [1] 0 0
ELX-CL-1805
Universal Trial Number (UTN)
Trial acronym
BIOADAPTOR RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Coronary Artery Stenosis 0 0
Coronary Disease 0 0
Coronary Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Percutaneous Coronary Intervention

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

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


Treatment: Devices: Percutaneous Coronary Intervention
Percutaneous coronary intervention of de novo native coronary artery lesions
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Target Lesion Failure (TLF)
Timepoint [1] 0 0
12 Months
Secondary outcome [1] 0 0
Percentage of Participants With Target Lesion Failure (TLF)
Timepoint [1] 0 0
Through 12 months post-procedure
Secondary outcome [2] 0 0
Percentage of Participants With Patient Oriented Clinical Endpoint
Timepoint [2] 0 0
Through 12 months
Secondary outcome [3] 0 0
Percentage of Participants With Composite of All-cause Mortality
Timepoint [3] 0 0
Through 12 months post-procedure
Secondary outcome [4] 0 0
Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization
Timepoint [4] 0 0
Through 12 months
Secondary outcome [5] 0 0
Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization
Timepoint [5] 0 0
Through 12 months
Secondary outcome [6] 0 0
Percentage of Participants With Cardiovascular Death, MI and Revascularization
Timepoint [6] 0 0
Through 12 months
Secondary outcome [7] 0 0
Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR)
Timepoint [7] 0 0
Through 12 months post-procedure
Secondary outcome [8] 0 0
Percentage of Participants With Target Lesion Revascularization (TLR)
Timepoint [8] 0 0
Through 12 months post-procedure
Secondary outcome [9] 0 0
Percentage of Participants With Target Vessel Revascularization (TVR)
Timepoint [9] 0 0
Through 12 months post-procedure
Secondary outcome [10] 0 0
Percentage of Participants With Clinically Indicated TVR (CI-TVR)
Timepoint [10] 0 0
Through 12 months post-procedure
Secondary outcome [11] 0 0
Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel)
Timepoint [11] 0 0
Through 12 months post procedure
Secondary outcome [12] 0 0
Percentage of Participants With Q-wave MI
Timepoint [12] 0 0
Through 12 months post-procedure
Secondary outcome [13] 0 0
Percentage of Participants With Non Q-wave MI
Timepoint [13] 0 0
Through 12 months post-procedure
Secondary outcome [14] 0 0
Percentage of Participants With MI (Target Vessel or Non-target Vessel)
Timepoint [14] 0 0
Through 12 months post procedure
Secondary outcome [15] 0 0
Percentage of Participants With Target Vessel MI
Timepoint [15] 0 0
Through 12 months post procedure
Secondary outcome [16] 0 0
Percentage of Participants With All-cause Mortality
Timepoint [16] 0 0
Through 12 months post-procedure
Secondary outcome [17] 0 0
Percentage of Participants With Cardiovascular Death
Timepoint [17] 0 0
Through 12 months post procedure
Secondary outcome [18] 0 0
Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI
Timepoint [18] 0 0
Through 12 months post procedure
Secondary outcome [19] 0 0
Percentage of Participants With Composite of All-cause Death or MI
Timepoint [19] 0 0
Through 12 months post-procedure
Secondary outcome [20] 0 0
Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR
Timepoint [20] 0 0
Through 12 months post-procedure
Secondary outcome [21] 0 0
Percentage of Participants With Composite of Probable or Definite Stent Thrombosis
Timepoint [21] 0 0
Through 12 months post-procedure
Secondary outcome [22] 0 0
Percentage of Participants With Probable Stent Thrombosis
Timepoint [22] 0 0
Through 12 months post-procedure
Secondary outcome [23] 0 0
Percentage of Participants With Definite Stent Thrombosis
Timepoint [23] 0 0
Through 12 months

Eligibility
Key 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
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
Accrual to date
Final
445
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Nauheim
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Segeberg
Country [7] 0 0
Germany
State/province [7] 0 0
Coburg
Country [8] 0 0
Germany
State/province [8] 0 0
Dortmund
Country [9] 0 0
Germany
State/province [9] 0 0
Erlangen
Country [10] 0 0
Germany
State/province [10] 0 0
Essen
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Giessen
Country [13] 0 0
Germany
State/province [13] 0 0
Jena
Country [14] 0 0
Germany
State/province [14] 0 0
Kiel
Country [15] 0 0
Germany
State/province [15] 0 0
Mainz
Country [16] 0 0
Germany
State/province [16] 0 0
Trier
Country [17] 0 0
Japan
State/province [17] 0 0
Fukuoka-Ken
Country [18] 0 0
Japan
State/province [18] 0 0
Hokkaido
Country [19] 0 0
Japan
State/province [19] 0 0
Ibaraki-Ken
Country [20] 0 0
Japan
State/province [20] 0 0
Kagoshima-Ken
Country [21] 0 0
Japan
State/province [21] 0 0
Kanagawa-Ken
Country [22] 0 0
Japan
State/province [22] 0 0
Kumamoto-Ken
Country [23] 0 0
Japan
State/province [23] 0 0
Miyazaki-Ken
Country [24] 0 0
Japan
State/province [24] 0 0
Shiga-Ken
Country [25] 0 0
Japan
State/province [25] 0 0
Tokyo
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Christchurch
Country [28] 0 0
New Zealand
State/province [28] 0 0
Dunedin
Country [29] 0 0
New Zealand
State/province [29] 0 0
Takapuna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Elixir Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT04192747
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shigeru Saito, MD
Address 0 0
Chief Director, Shonan Kamakura General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04192747