Coronary Artery Stenosis
Conditions
Keywords
CAD, PCI, ACS, non ACS, BioNIR, DES
Brief summary
The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute). The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary endpoint of angiographic in-stent late loss at 6 months.
Detailed description
This is a prospective, multi-center, single-blind, two-arm, 2:1 randomized clinical trial. Randomization will be stratified by the presence of medically treated diabetes vs. no medically treated diabetes and by site. Lesions planned to be treated must be declared and recorded at time of randomization. Angiographic follow-up will be performed at 6 months. Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. The Primary Endpoint is in-stent late loss at 6 months as measured by the angiographic core laboratory. Angiographic Secondary Endpoints to be evaluated at 6 months are: * In-segment late loss * Follow-up percent diameter stenosis (in-stent and in-segment) * Binary restenosis (in-stent and in-segment) * Length and patterns of angiographic restenosis (Mehran classification) Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5 years, except as noted, are: * Device, Lesion, and Procedure Success at time of baseline procedure * Target lesion failure (TLF; the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR) * Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR) * Target vessel failure (TVF; the composite rate of death, target vessel-related MI, or ischemia-driven TVR) * Overall Mortality * Cardiac Death * Myocardial Infarction * Target Vessel Related MI * Ischemia-driven TLR * Ischemia-driven TVR * Stent Thrombosis (ARC definite and probable)
Sponsors
Medinol Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a Drug-Device combination Product
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked. * Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: \<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see
Exclusion criteria
#3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated. * Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic inclusion criteria (visual estimate): * Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel * Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to \<100%. * Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent). * TIMI flow 2 or 3 * If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent late loss | 6 months | In-stent late loss as measured by the angiographic core laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up percent diameter stenosis | 6 months | angiographic: Follow-up percent diameter stenosis (in-stent and in-segment) |
| Binary restenosis | 6 months | angiographic: Binary restenosis (in-stent and in-segment) |
| Length and patterns of angiographic restenosis | 6 months | angiographic: Mehran classification |
| Device, Lesion, and Procedure Success | Determined at time of baseline procedure | Device success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only and without a device malfunction. Lesion success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using any percutaneous method. Procedure success is defined as achievement of a final in-stent diameter stenosis of \<50% (by QCA) using the assigned device and/or with any adjunctive devices, without the occurrence of cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay. |
| Target lesion failure | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | Clinical: TLF, the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR |
| Major Adverse Cardiac Events (MACE) | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | Clinical: MACE, the composite rate of cardiac death, any MI or ischemia-driven TLR |
| In-segment late loss | 6 months | angiographic secondary endpoint |
| Overall Mortality | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | Clinical: Overall mortality during the trial period |
| Cardiac death | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | Clinical measure: The number of patients who suffered cardiac death |
| Myocardial Infarction | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | Clinical: myocardial infarction |
| Target vessel related MI | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | clinical: target vessel related MI |
| Ischemia driven TLR and TVR | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | clinical: TLR and TVR |
| Stent Thrombosis | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | clinical: Stent Thrombosis (ARC definite and probable) |
| Target vessel failure | 30 days, 6 months, and 1, 2, 3, 4 and 5 years | TVF, the composite rate of death, target vessel-related MI, or ischemia-driven TVR |
Countries
Israel
Outcome results
None listed