Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
Conditions
Keywords
Coronary Ste, Bioadaptor, Percutaneous Coronary Intervention
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
Interventions
DEVICEPercutaneous Coronary Intervention
Percutaneous coronary intervention of de novo native coronary artery lesions
Sponsors
Elixir Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Single-blind, 1:1 Randomized trial of parallel design
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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) 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) | 12 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinically Indicated TVR (CI-TVR) | Through 12 months post-procedure | Re-PCI or CABG in the target vessel due to restenosis or other complications |
| Percentage of Participants With Target Lesion Failure (TLF) | Through 12 months post-procedure | TLF is a composite endpoint defined as cardiovascular death, target-vessel MI, and Clinically-Indicated TLR |
| Percentage of Participants With Patient Oriented Clinical Endpoint | Through 12 months | 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) |
| Percentage of Participants With Composite of All-cause Mortality | Through 12 months post-procedure | A composite of all-cause mortality, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel) |
| Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization | Through 12 months | Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR) |
| Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization | Through 12 months | Composite of cardiovascular death, stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel) |
| Percentage of Participants With Cardiovascular Death, MI and Revascularization | Through 12 months | Composite of cardiovascular death, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel) |
| Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR) | Through 12 months post-procedure | Number of Patients with Clinically Indicated Target Lesion Revascularization (CI-TLR) |
| Percentage of Participants With Target Lesion Revascularization (TLR) | Through 12 months post-procedure | Target lesion revascularization |
| Percentage of Participants With Target Vessel Revascularization (TVR) | Through 12 months post-procedure | Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications |
| Percentage of Participants With Q-wave MI | Through 12 months post-procedure | 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. |
| Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel) | Through 12 months post procedure | Revascularization of the target vessel or non-target vessel due to in-segment restenosis or other complications |
| Percentage of Participants With MI (Target Vessel or Non-target Vessel) | Through 12 months post procedure | MI is defined as per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With Target Vessel MI | Through 12 months post procedure | MI is defined as per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With All-cause Mortality | Through 12 months post-procedure | As defined per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With Cardiovascular Death | Through 12 months post procedure | As defined as per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI | Through 12 months post procedure | Target Vessel Related Death or MI |
| Percentage of Participants With Composite of All-cause Death or MI | Through 12 months post-procedure | Target vessel or non-target vessel related death or MI |
| Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR | Through 12 months post-procedure | Any Death, any MI and any Target Vessel Revascularization |
| Percentage of Participants With Composite of Probable or Definite Stent Thrombosis | Through 12 months post-procedure | Defined as per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With Probable Stent Thrombosis | Through 12 months post-procedure | Defined as per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With Definite Stent Thrombosis | Through 12 months | Defined as per the Academic Research Consortium (ARC-2) criteria |
| Percentage of Participants With Non Q-wave MI | Through 12 months post-procedure | 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. |
Countries
Belgium, Germany, Japan, New Zealand
Participant flow
Recruitment details
Study recruitment and enrollment took place at 34 global centers including 14 in Japan and 20 in Europe between December 2020 to February 2022. A total of 445 patients with de novo coronary artery lesions were enrolled and randomly assigned to either the DynamX arm or the Resolute Onyx arm.
Participants by arm
| Arm | Count |
|---|---|
| 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
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions | 223 |
| 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
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions | 222 |
| Total | 445 |
Baseline characteristics
| Characteristic | Medtronic Resolute Onyx Stent | Total | Elixir Bioadaptor (ELX1805J) |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 10.1 | 66.6 years STANDARD_DEVIATION 10.2 | 67.1 years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 113 Participants | 223 Participants | 110 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 36 Participants | 17 Participants |
| Race (NIH/OMB) White | 89 Participants | 183 Participants | 94 Participants |
| Sex: Female, Male Female | 49 Participants | 98 Participants | 49 Participants |
| Sex: Female, Male Male | 173 Participants | 347 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 222 | 3 / 216 |
| other Total, other adverse events | 128 / 223 | 124 / 222 |
| serious Total, serious adverse events | 60 / 223 | 44 / 222 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Target Lesion Failure (TLF) | 1.81 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Target Lesion Failure (TLF) | 2.79 percentage of participants |
Secondary
Percentage of Participants With All-cause Mortality
As defined per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post-procedure
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With All-cause Mortality | 0.5 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With All-cause Mortality | 1.4 percentage of participants |
Secondary
Percentage of Participants With Cardiovascular Death
As defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post procedure
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Cardiovascular Death | 0.0 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Cardiovascular Death | 0.9 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Cardiovascular Death, MI and Revascularization | 6.3 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Cardiovascular Death, MI and Revascularization | 7.4 percentage of participants |
Secondary
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)
Time frame: Through 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization | 6.3 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization | 7.4 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR) | 0.9 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR) | 0.5 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Clinically Indicated TVR (CI-TVR) | 0.9 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Clinically Indicated TVR (CI-TVR) | 1.4 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR | 2.7 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR | 4.6 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Composite of All-cause Death or MI | 1.8 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Composite of All-cause Death or MI | 3.2 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Composite of All-cause Mortality | 6.8 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Composite of All-cause Mortality | 7.9 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI | 1.4 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI | 2.8 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization | 1.8 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization | 3.7 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Composite of Probable or Definite Stent Thrombosis | 0.5 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Composite of Probable or Definite Stent Thrombosis | 0.5 percentage of participants |
Secondary
Percentage of Participants With Definite Stent Thrombosis
Defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Definite Stent Thrombosis | 0.5 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Definite Stent Thrombosis | 0 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With MI (Target Vessel or Non-target Vessel) | 1.4 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With MI (Target Vessel or Non-target Vessel) | 1.9 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Non Q-wave MI | 0.9 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Non Q-wave MI | 0.9 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Patient Oriented Clinical Endpoint | 6.8 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Patient Oriented Clinical Endpoint | 7.9 percentage of participants |
Secondary
Percentage of Participants With Probable Stent Thrombosis
Defined as per the Academic Research Consortium (ARC-2) criteria
Time frame: Through 12 months post-procedure
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Probable Stent Thrombosis | 0 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Probable Stent Thrombosis | 0.5 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Q-wave MI | 0.0 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Q-wave MI | 0.9 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel) | 5.4 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel) | 5.2 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Target Lesion Failure (TLF) | 1.8 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Target Lesion Failure (TLF) | 2.8 percentage of participants |
Secondary
Percentage of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization
Time frame: Through 12 months post-procedure
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Target Lesion Revascularization (TLR) | 1.4 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Target Lesion Revascularization (TLR) | 0.9 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Target Vessel MI | 1.4 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Target Vessel MI | 1.9 percentage of participants |
Secondary
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
Population: The denominator reflects the number of evaluable participants for the outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elixir Bioadaptor (ELX1805J) | Percentage of Participants With Target Vessel Revascularization (TVR) | 1.4 percentage of participants |
| Medtronic Resolute Onyx Stent | Percentage of Participants With Target Vessel Revascularization (TVR) | 1.9 percentage of participants |