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

NCT ID: NCT04192747

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 445 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2027-02-28

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

Conditions

Coronary Artery Disease; Coronary Artery Stenosis; Coronary Disease; Coronary Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type: DEVICE

Percutaneous coronary intervention of de novo native coronary artery lesions

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

Group Type: ACTIVE_COMPARATOR

Percutaneous Coronary Intervention

Intervention Type: DEVICE

Percutaneous coronary intervention of de novo native coronary artery lesions

Interventions

Percutaneous Coronary Intervention

Percutaneous coronary intervention of de novo native coronary artery lesions

Intervention Type: DEVICE

Eligibility Criteria

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.

Exclusion Criteria

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elixir Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Chief Director, Shonan Kamakura General Hospital

Locations

AZ Middelheim Hospital

Antwerp, , Belgium

AZ Sint Jan Brugge

Bruges, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Kerkhoff Klinik GmbH

Bad Nauheim, , Germany

Segeberger Kliniken GmbH

Bad Segeberg, , Germany

REGIOMED Klinikum Coburg

Coburg, , Germany

St. Johannes Hospital

Dortmund, , Germany

Universitatsklinikum Erlangen

Erlangen, , Germany

Elisabeth Krankenhaus Essen

Essen, , Germany

MVZ CCB Frankfurt

Frankfurt, , Germany

Universitatsklinikun Giessen

Giessen, , Germany

Universitätsklinikum Jena

Jena, , Germany

UKSH Kiel Klinik

Kiel, , Germany

Universitätsmedizin-Mainz

Mainz, , Germany

Krankenhaus der barmherzigen Bruder

Trier, , Germany

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Shinkoga Hospital

Kurume, Fukuoka, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Takahashi Hospital

Tsuchiura, Ibaraki, Japan

Tsuchiura Kyodo Hospital

Tsuchiura, Ibaraki, Japan

Tenyokai Central Hospital

Kagoshima, Kagoshima-ken, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Kanto Rosai Hospital

Kawasaki-shi, Kanagawa, Japan

Yokohama City Eastern Hospital

Yokohama, Kanagawa, Japan

Kumamoto Rousai Hospital

Kumamoto, Kumamoto, Japan

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Oumi Hachiman City General Medical Center

Hachiman, Shiga, Japan

Cardiovascular Reaearch Institute

Tokyo, , Japan

Teikyo University Hospital

Tokyo, , Japan

Auckland City Hospital

Auckland, , New Zealand

Middlemore Clinical Trials Trust

Auckland, , New Zealand

Waikato Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

North Shore Hospital

Takapuna, , New Zealand

Countries

Belgium; Germany; Japan; New Zealand

References

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.

Reference Type: DERIVED

PMID: 40057888 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38106564 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ELX-CL-1805

Identifier Type: -

Identifier Source: org_study_id