The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding. Patients will undergo PCI with implantation of the EluNIR stent, followed by shortened duration (1 months in stable patients, and up to 3 months in ACS patients) of DAPT.
This is a prospective, multi-center (Up to 20 sites), single-arm, open-label post marketing clinical trial. The objectives: To assess the safety and efficacy of shortened DAPT duration (30 days in stable patients and up to 90 days in ACS patients) following PCI using the EluNIR stent, in patients considered to be at high bleeding risk (HBR). Patients will be enrolled to the study prior to the PCI procedure.Once a patient has signed an informed consent, met all general and angiographic eligibility criteria, and a guidewire has successfully been passed beyond the target lesion and lesion preparation (if indicated) completed, the patient will be enrolled into the trial.Data collection commences after the subject has signed the informed consent form. Data collection including subject demographic information, laboratory tests, and procedural data as well as follow-up visits or telephone contacts will be captured by the Investigator or site coordinator who has been trained on the CIP and Case Report Forms (CRF). After discharge from the hospital, each subject will be followed with an in-clinic follow-up visit at 30 days, and follow-up by phone at 6 months and 1year post procedure. Patients with recurrent ischemic events within the first 30 days as well as patients in whom the initial presentation was ACS and in whom the investigator has decided to continue DAPT beyond 30 days will have an additional phone follow-up at 3 months. The clinical investigation will last for the expected duration of each subject's participation. Each subject will remain in the clinical investigation for approximately 1 year from the time of the study stent implantation until the last follow-up telephone contact. The trial population will consist of approximately 316 male and female subjects undergoing PCI for angina (stable or unstable), silent ischemia, non-ST elevation MI (NSTEMI) considered at HBR.
Study Type
OBSERVATIONAL
Enrollment
319
Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines.
Medinol LTD
Tel Aviv, Israel
The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable)
Time frame: 1 Year
TLF, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR)
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
Time frame: To be evaluated at 30 days, 6 months, and 1 year
The composite of cardiac death, myocardial infarction, or stent thrombosis at 30 days and 6 months
Time frame: To be evaluated at 30 days, 6 months, and 1 year
All-cause mortality
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Cardiac death
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Bleeding events according to BARC definitions
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Myocardial Infarction
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Target Vessel Related MI
Time frame: To be evaluated at 30 days, 6 months, and 1 year
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Ischemia-driven TLR
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Ischemia-driven TVR
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Stent Thrombosis (ARC definite and probable)
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Bleeding complications (BARC definitions), evaluated as components and as a composite of BARC Type 3 and 5 bleeding
Time frame: To be evaluated at 30 days, 6 months, and 1 year