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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
445
Percutaneous coronary intervention of de novo native coronary artery lesions
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
Time frame: 12 Months
Percentage of Participants With Target Lesion Failure (TLF)
TLF is a composite endpoint defined as cardiovascular death, target-vessel MI, and Clinically-Indicated TLR
Time frame: Through 12 months post-procedure
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)
Time frame: Through 12 months
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)
Time frame: Through 12 months post-procedure
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)
Time frame: Through 12 months
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)
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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
...and 26 more locations
Time frame: Through 12 months
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)
Time frame: Through 12 months
Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR)
Number of Patients with Clinically Indicated Target Lesion Revascularization (CI-TLR)
Time frame: Through 12 months post-procedure
Percentage of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization
Time frame: Through 12 months post-procedure
Percentage of Participants With Target Vessel Revascularization (TVR)
Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications
Time frame: Through 12 months post-procedure
Percentage of Participants With Clinically Indicated TVR (CI-TVR)
Re-PCI or CABG in the target vessel due to restenosis or other complications
Time frame: Through 12 months post-procedure
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
Time frame: Through 12 months post procedure
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.
Time frame: Through 12 months post-procedure
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.
Time frame: Through 12 months post-procedure
Percentage of Participants With MI (Target Vessel or Non-target Vessel)
MI is defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post procedure
Percentage of Participants With Target Vessel MI
MI is defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post procedure
Percentage of Participants With All-cause Mortality
As defined per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post-procedure
Percentage of Participants With Cardiovascular Death
As defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post procedure
Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI
Target Vessel Related Death or MI
Time frame: Through 12 months post procedure
Percentage of Participants With Composite of All-cause Death or MI
Target vessel or non-target vessel related death or MI
Time frame: Through 12 months post-procedure
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
Time frame: Through 12 months post-procedure
Percentage of Participants With Composite of Probable or Definite Stent Thrombosis
Defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post-procedure
Percentage of Participants With Probable Stent Thrombosis
Defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post-procedure
Percentage of Participants With Definite Stent Thrombosis
Defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months