Clinical trial NCT04192747: The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Keywords: Coronary Ste
Bioadaptor
Percutaneous Coronary Intervention
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 445
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, 1:1 Randomized trial of parallel design
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Target Lesion Failure (TLF)
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Participants With Target Lesion Failure (TLF)
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Patient Oriented Clinical Endpoint
timeFrame: Through 12 months
measure: Percentage of Participants With Composite of All-cause Mortality
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization
timeFrame: Through 12 months
measure: Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization
timeFrame: Through 12 months
measure: Percentage of Participants With Cardiovascular Death, MI and Revascularization
timeFrame: Through 12 months
measure: Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR)
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Target Lesion Revascularization (TLR)
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Target Vessel Revascularization (TVR)
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Clinically Indicated TVR (CI-TVR)
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel)
timeFrame: Through 12 months post procedure
measure: Percentage of Participants With Q-wave MI
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Non Q-wave MI
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With MI (Target Vessel or Non-target Vessel)
timeFrame: Through 12 months post procedure
measure: Percentage of Participants With Target Vessel MI
timeFrame: Through 12 months post procedure
measure: Percentage of Participants With All-cause Mortality
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Cardiovascular Death
timeFrame: Through 12 months post procedure
measure: Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI
timeFrame: Through 12 months post procedure
measure: Percentage of Participants With Composite of All-cause Death or MI
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Composite of Probable or Definite Stent Thrombosis
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Probable Stent Thrombosis
timeFrame: Through 12 months post-procedure
measure: Percentage of Participants With Definite Stent Thrombosis
timeFrame: Through 12 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: AZ Middelheim Hospital
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Bad Nauheim
country: Germany
facility: Kerkhoff Klinik GmbH
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Coburg
country: Germany
facility: REGIOMED Klinikum Coburg
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Frankfurt
country: Germany
facility: MVZ CCB Frankfurt
city: Giessen
country: Germany
facility: Universitatsklinikun Giessen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kiel
country: Germany
facility: UKSH Kiel Klinik
city: Mainz
country: Germany
facility: Universitätsmedizin-Mainz
city: Trier
country: Germany
facility: Krankenhaus der barmherzigen Bruder
city: Kitakyushu City
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka-Ken
city: Kurume City
country: Japan
facility: Shinkoga Hospital
state: Fukuoka-Ken
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Tsuchiura City
country: Japan
facility: Takahashi Hospital
state: Ibaraki-Ken
city: Tsuchiura City
country: Japan
facility: Tsuchiura Kyodo Hospital
state: Ibaraki-Ken
city: Kagoshima City
country: Japan
facility: Tenyokai Central Hospital
state: Kagoshima-Ken
city: Kamakura City,
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa-Ken
city: Kawasaki-shi
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Yokohama City Eastern Hospital
state: Kanagawa-Ken
city: Kumamoto
country: Japan
facility: Kumamoto Rousai Hospital
state: Kumamoto-Ken
city: Miyazaki City
country: Japan
facility: Miyazaki Medical Association Hospital
state: Miyazaki-Ken
city: Hachiman
country: Japan
facility: Oumi Hachiman City General Medical Center
state: Shiga-Ken
city: Tokyo
country: Japan
facility: Cardiovascular Reaearch Institute
city: Tokyo
country: Japan
facility: Teikyo University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials Trust
city: Auckland
country: New Zealand
facility: Waikato Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Takapuna
country: New Zealand
facility: North Shore Hospital
Study officials:
affiliation: Chief Director, Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References: