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

NCT04192747 | Active Not Recruiting Results FDA Device

• 1 other identifier: ELX-CL-1805
• Study Type: interventional
• Target: 445
• Locations: 4 countries
• Sites: 36

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

Conditions

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

Keywords

Coronary Ste; Bioadaptor; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (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

  12 Months

Secondary Outcomes (23)

• Percentage of Participants With Target Lesion Failure (TLF)

  Through 12 months post-procedure

• Percentage of Participants With Patient Oriented Clinical Endpoint

  Through 12 months

• Percentage of Participants With Composite of All-cause Mortality

  Through 12 months post-procedure

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

  Through 12 months

• Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization

  Through 12 months

Study Arms (2)

Elixir Bioadaptor (ELX1805J)

EXPERIMENTAL

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

Medtronic Resolute Onyx Stent

ACTIVE COMPARATOR

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

Interventions

Percutaneous Coronary Intervention DEVICE

Percutaneous coronary intervention of de novo native coronary artery lesions

Elixir Bioadaptor (ELX1805J); Medtronic Resolute Onyx Stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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%

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (36)

AZ Middelheim Hospital

Antwerp, Belgium

Location

AZ Sint Jan Brugge

Bruges, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Kerkhoff Klinik GmbH

Bad Nauheim, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, Germany

Location

REGIOMED Klinikum Coburg

Coburg, Germany

Location

St. Johannes Hospital

Dortmund, Germany

Location

Universitatsklinikum Erlangen

Erlangen, Germany

Location

Elisabeth Krankenhaus Essen

Essen, Germany

Location

MVZ CCB Frankfurt

Frankfurt, Germany

Location

Universitatsklinikun Giessen

Giessen, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

UKSH Kiel Klinik

Kiel, Germany

Location

Universitätsmedizin-Mainz

Mainz, Germany

Location

Krankenhaus der barmherzigen Bruder

Trier, Germany

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Shinkoga Hospital

Kurume, Fukuoka, Japan

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Location

Takahashi Hospital

Tsuchiura, Ibaraki, Japan

Location

Tsuchiura Kyodo Hospital

Tsuchiura, Ibaraki, Japan

Location

Tenyokai Central Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Kanto Rosai Hospital

Kawasaki-shi, Kanagawa, Japan

Location

Yokohama City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Kumamoto Rousai Hospital

Kumamoto, Kumamoto, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Location

Oumi Hachiman City General Medical Center

Hachiman, Shiga, Japan

Location

Cardiovascular Reaearch Institute

Tokyo, Japan

Location

Teikyo University Hospital

Tokyo, Japan

Location

Auckland City Hospital

Auckland, New Zealand

Location

Middlemore Clinical Trials Trust

Auckland, New Zealand

Location

Waikato Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

North Shore Hospital

Takapuna, New Zealand

Location

Related Publications (2)

• 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.

  PMID: 40057888 DERIVED

• 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.

  PMID: 38106564 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Coronary Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Tina Cordaro, Sr. Director, Clinical Trials
• Organization: Elixir Medical Corporation

tcordaro@ElixirMedical.com

585-360-7270

Study Officials

• Shigeru Saito, MD

  Chief Director, Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-blind, 1:1 Randomized trial of parallel design

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: December 16, 2020
• Primary Completion: February 28, 2023
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 24, 2025
• Results First Posted: October 22, 2024

Record last verified: 2025-03

Locations

BE (4); NZ (6); JP (14); DE (12)