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

Sponsor
Elixir Medical Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04192747
Collaborator
(none)
444
36
2
74.4
12.3
0.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Percutaneous Coronary Intervention
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
444 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blind, 1:1 Randomized trial of parallel designSingle-blind, 1:1 Randomized trial of parallel design
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805
Actual Study Start Date :
Dec 16, 2020
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
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

Device: Percutaneous Coronary Intervention
Percutaneous coronary intervention of de novo native coronary artery lesions

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

Device: Percutaneous Coronary Intervention
Percutaneous coronary intervention of de novo native coronary artery lesions

Outcome Measures

Primary Outcome Measures

  1. Number of Patients with Target Lesion Failure (TLF) [12 Months]

    TLF is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated

Secondary Outcome Measures

  1. Number of Patients with Target Lesion Failure (TLF) [30 Days, 180 Days, 2, 3, 4 and 5 years]

    TLF is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated

  2. Number of Patients with Patient Oriented Clinical Endpoint [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    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)

  3. Number of Patients with Composite of All-cause mortality [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    A composite of all-cause mortality, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)

  4. Number of Patients with Composite of Cardiac Death TVMI and ID-TVR revascularization [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR)

  5. Number of Patients with Cardiac death, stroke, MI and revascularization [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Composite of cardiac death, stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)

  6. Number of Patients with Cardiac death, MI and revascularization [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Composite of cardiac death, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)

  7. Number of Patients with Ischemia Driven Target Lesion Revascularization (ID-TLR) [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Ischemia driven target lesion revascularization

  8. Number of Patients with Target Lesion Revascularization (TLR) [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Target lesion revascularization

  9. Number of Patients with Target Vessel Revascularization (TVR) [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications

  10. Number of Patients with Ischemia driven TVR (ID-TVR) [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Re-PCI or CABG in the target vessel due to restenosis or other complications

  11. Number of Patients with Revascularization (target vessel or non-target vessel) [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications

  12. Number of Patients with Q-wave MI [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    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.

  13. Number of Patients with Non Q-wave MI [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    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.

  14. Number of Patients with MI (target vessel or non-target vessel) [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    per ARC II

  15. Number of Patients with Target Vessel MI [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    per ARC II

  16. Number of Patients with All-cause Death [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Per ARC II Definitions

  17. Number of Patients with Cardiac Death [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Per ARC II Definitions

  18. Number of Patients with Composite of Cardiac Death or Target Vessel MI [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Target Vessel Related Death or MI

  19. Number of Patients with Composite of all-cause Death or MI [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    target vessel or non-target vessel related death or MI

  20. Number of Patients with Composite of all-cause Death, MI (target vessel or non-target vessel), or TVR [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Any Death, any MI and any Target Vessel Revascularization

  21. Number of Patients with Composite of Probable or Definite Stent Thrombosis [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Per ARC II Definitions

  22. Number of Patients with Probable Stent Thrombosis [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Per ARC II Definitions

  23. Number of Patients with Definite Stent Thrombosis [30 Days, 180 Days, 1, 2, 3, 4 and 5 years]

    Per ARC II Definitions

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

  1. 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

  1. Patients suspected or confirmed with the QCA analysis of having stenotic lesion of more than 50% in target vessel in addition to target lesion

  2. Patients with target lesion in ostia located within 5 mm of origin of LAD, LCX or RCA

  3. Patients with stenotic lesion in left main trunk

  4. Patients with target lesion that is a chronic total occlusion (CTO) or ≤ TIMI 1 coronary flow in the target vessel

  5. Patients with target vessel that contains thrombus as indicated in pre-procedure angiographic, IVUS or OCT images

  6. Excessive tortuosity ≥ two 45° angles or extreme angulation (≥ 90°) proximal to or within the target lesion

  7. 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.

  8. 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

  9. Patients with 2 or more target lesions on 1 branch or target lesions on 3 branches that need to be treated during study procedure

  10. Target lesion involves a myocardial bridge

Contacts and Locations

Locations

Site City State Country Postal Code
1 AZ Middelheim Hospital Antwerp Belgium
2 AZ Sint Jan Brugge Brugge Belgium
3 Ziekenhuis Oost-Limburg Genk Belgium
4 Universitaire Ziekenhuizen Leuven Leuven Belgium
5 Kerkhoff Klinik GmbH Bad Nauheim Germany
6 Segeberger Kliniken GmbH Bad Segeberg Germany
7 REGIOMED Klinikum Coburg Coburg Germany
8 St. Johannes Hospital Dortmund Germany
9 Universitatsklinikum Erlangen Erlangen Germany
10 Elisabeth Krankenhaus Essen Essen Germany
11 MVZ CCB Frankfurt Frankfurt Germany
12 Universitatsklinikun Giessen Giessen Germany
13 Universitätsklinikum Jena Jena Germany
14 UKSH Kiel Klinik Kiel Germany
15 Universitätsmedizin-Mainz Mainz Germany
16 Krankenhaus der barmherzigen Bruder Trier Germany
17 Kokura Memorial Hospital Kitakyushu City Fukuoka-Ken Japan
18 Shinkoga Hospital Kurume City Fukuoka-Ken Japan
19 Sapporo Higashi Tokushukai Hospital Sapporo Hokkaido Japan
20 Takahashi Hospital Tsuchiura City Ibaraki-Ken Japan
21 Tsuchiura Kyodo Hospital Tsuchiura City Ibaraki-Ken Japan
22 Tenyokai Central Hospital Kagoshima City Kagoshima-Ken Japan
23 Shonan Kamakura General Hospital Kamakura City, Kanagawa-Ken Japan
24 Kanto Rosai Hospital Kawasaki-shi Kanagawa-Ken Japan
25 Yokohama City Eastern Hospital Yokohama-shi Kanagawa-Ken Japan
26 Kumamoto Rousai Hospital Kumamoto Kumamoto-Ken Japan
27 Miyazaki Medical Association Hospital Miyazaki City Miyazaki-Ken Japan
28 Oumi Hachiman City General Medical Center Hachiman Shiga-Ken Japan
29 Cardiovascular Reaearch Institute Tokyo Japan
30 Teikyo University Hospital Tokyo Japan
31 Auckland City Hospital Auckland New Zealand
32 Middlemore Clinical Trials Trust Auckland New Zealand
33 Waikato Hospital Auckland New Zealand
34 Christchurch Hospital Christchurch New Zealand
35 Dunedin Hospital Dunedin New Zealand
36 North Shore Hospital Takapuna New Zealand

Sponsors and Collaborators

  • Elixir Medical Corporation

Investigators

  • Principal Investigator: Shigeru Saito, MD, Chief Director, Shonan Kamakura General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elixir Medical Corporation
ClinicalTrials.gov Identifier:
NCT04192747
Other Study ID Numbers:
  • ELX-CL-1805
First Posted:
Dec 10, 2019
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
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
Keywords provided by Elixir Medical Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022