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Coronary Artery DiseaseBIOADAPTOR RCTNCT04192747

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

A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Elixir Medical Corporation at 36 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Percutaneous Coronary Intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
445 participants
Where
36 sitesin 4 countries
Study dates
16 Dec 2020to 28 Feb 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 24Show fewer
  • 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

Who cannot join

  • 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%
Show all 36Show fewer
  • 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

Trial locations and contacts

36 sites in 4 countries.

36 sites in 4 countries

Japan14 sites

  • Oumi Hachiman City General Medical Center

    Hachiman, Shiga

  • Tenyokai Central Hospital

    Kagoshima, Kagoshima-ken

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa

  • Kanto Rosai Hospital

    Kawasaki-shi, Kanagawa

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka

  • Kumamoto Rousai Hospital

    Kumamoto, Kumamoto

  • Shinkoga Hospital

    Kurume, Fukuoka

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido

  • Cardiovascular Reaearch Institute

    Tokyo

  • Teikyo University Hospital

    Tokyo

  • Takahashi Hospital

    Tsuchiura, Ibaraki

  • Tsuchiura Kyodo Hospital

    Tsuchiura, Ibaraki

  • Yokohama City Eastern Hospital

    Yokohama, Kanagawa

Other trials in Japan

Germany12 sites

  • Kerkhoff Klinik GmbH

    Bad Nauheim

  • Segeberger Kliniken GmbH

    Bad Segeberg

  • REGIOMED Klinikum Coburg

    Coburg

  • St. Johannes Hospital

    Dortmund

  • Universitatsklinikum Erlangen

    Erlangen

  • Elisabeth Krankenhaus Essen

    Essen

  • MVZ CCB Frankfurt

    Frankfurt

  • Universitatsklinikun Giessen

    Giessen

  • Universitätsklinikum Jena

    Jena

  • UKSH Kiel Klinik

    Kiel

  • Universitätsmedizin-Mainz

    Mainz

  • Krankenhaus der barmherzigen Bruder

    Trier

Other trials in Germany

New Zealand6 sites

  • Auckland City Hospital

    Auckland

  • Middlemore Clinical Trials Trust

    Auckland

  • Waikato Hospital

    Auckland

  • Christchurch Hospital

    Christchurch

  • Dunedin Hospital

    Dunedin

  • North Shore Hospital

    Takapuna

Other trials in New Zealand

Belgium4 sites

  • AZ Middelheim Hospital

    Antwerp

  • AZ Sint Jan Brugge

    Bruges

  • Ziekenhuis Oost-Limburg

    Genk

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

About this study

Official title: Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De Novo Native Coronary Arteries ELX-CL-1805

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

Read the 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

Being tested
Percutaneous Coronary Intervention
Keywords
Coronary Ste, Bioadaptor, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionDevice

    Percutaneous coronary intervention of de novo native coronary artery lesions

Study groups in NCT04192747
Study groupRoleWhat they receive
Elixir Bioadaptor (ELX1805J)ExperimentalThe Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Receives: Device: Percutaneous Coronary Intervention
Medtronic Resolute Onyx StentActive comparatorThe Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Receives: Device: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Target Lesion Failure (TLF)

    The primary endpoint of the BIOADAPTOR RCT is Target Lesion Failure (TLF), which is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated TLR

    Measured: 12 Months

Secondary outcomes (23)

  1. Percentage of Participants With Target Lesion Failure (TLF)

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

    Measured: Through 12 months post-procedure

  2. Percentage of Participants 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)

    Measured: Through 12 months

  3. Percentage of Participants 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)

    Measured: Through 12 months post-procedure

  4. Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization

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

    Measured: Through 12 months

  5. Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization

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

    Measured: Through 12 months

  6. Percentage of Participants With Cardiovascular Death, MI and Revascularization

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

    Measured: Through 12 months

  7. Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR)

    Number of Patients with Clinically Indicated Target Lesion Revascularization (CI-TLR)

    Measured: Through 12 months post-procedure

  8. Percentage of Participants With Target Lesion Revascularization (TLR)

    Target lesion revascularization

    Measured: Through 12 months post-procedure

  9. Percentage of Participants With Target Vessel Revascularization (TVR)

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

    Measured: Through 12 months post-procedure

  10. Percentage of Participants With Clinically Indicated TVR (CI-TVR)

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

    Measured: Through 12 months post-procedure

  11. Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel)

    Revascularization of the target vessel or non-target vessel due to in-segment restenosis or other complications

    Measured: Through 12 months post procedure

  12. Percentage of Participants 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.

    Measured: Through 12 months post-procedure

  13. Percentage of Participants 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.

    Measured: Through 12 months post-procedure

  14. Percentage of Participants With MI (Target Vessel or Non-target Vessel)

    MI is defined as per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months post procedure

  15. Percentage of Participants With Target Vessel MI

    MI is defined as per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months post procedure

  16. Percentage of Participants With All-cause Mortality

    As defined per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months post-procedure

  17. Percentage of Participants With Cardiovascular Death

    As defined as per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months post procedure

  18. Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI

    Target Vessel Related Death or MI

    Measured: Through 12 months post procedure

  19. Percentage of Participants With Composite of All-cause Death or MI

    Target vessel or non-target vessel related death or MI

    Measured: Through 12 months post-procedure

  20. Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR

    Any Death, any MI and any Target Vessel Revascularization

    Measured: Through 12 months post-procedure

  21. Percentage of Participants With Composite of Probable or Definite Stent Thrombosis

    Defined as per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months post-procedure

  22. Percentage of Participants With Probable Stent Thrombosis

    Defined as per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months post-procedure

  23. Percentage of Participants With Definite Stent Thrombosis

    Defined as per the Academic Research Consortium (ARC-2) criteria

    Measured: Through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start16 Dec 2020
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind, 1:1 Randomized trial of parallel design
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192747
Sponsor's protocol ID
ELX-CL-1805
Acronym
BIOADAPTOR RCT
Status last verified
Mar 2025
First submitted
6 Dec 2019
Last updated
24 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Saito S, Bennett J, Nef HM, Webster M, Namiki A, Takahashi A, Kakuta T, Yamazaki S, Shibata Y, Scott D, Vrolix M, Menon M, Mollmann H, Werner N, Neylon A, Mehmedbegovic Z, Smits PC, Morice MC, Verheye S; BIOADAPTOR-RCT Collaborators. Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT. JACC Cardiovasc Interv. 2025 Apr 28;18(8):988-997. doi: 10.1016/j.jcin.2025.01.426. Epub 2025 Feb 26.

    PubMed 40057888

  • Erlinge D, Andersson J, Frobert O, Tornerud M, Bohm F, Held C, Elek C, Sirhan M, Oldgren J, James S. Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent. Am Heart J. 2024 Nov;277:1-10. doi: 10.1016/j.ahj.2024.07.016. Epub 2024 Aug 2.

    PubMed 39098754

  • Saito S, Bennett J, Nef HM, Webster M, Namiki A, Takahashi A, Kakuta T, Yamazaki S, Shibata Y, Scott D, Vrolix M, Menon M, Mollmann H, Werner N, Neylon A, Mehmedbegovic Z, Smits PC, Morice MC, Verheye S; BIOADAPTOR-RCT Collaborators. First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT. EClinicalMedicine. 2023 Oct 24;65:102304. doi: 10.1016/j.eclinm.2023.102304. eCollection 2023 Nov.

    PubMed 38106564

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Elixir Medical Corporation at 36 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Japan, Germany, New Zealand, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Target Lesion Failure (TLF) (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04192747, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

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