Clinical trial NCT03877848: EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
Official title: EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Keywords: bleeding
PCI
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-18
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High bleeding risk subjects undergoing PCI using the EluNIR stent for angina, silent ischemia or non STEMI.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

All inclusion criteria must be present for the patient to be eligible for enrollment.

General Inclusion Criteria

1. Age ≥ 18 years.
2. Patient with angina (stable or unstable), silent ischemia or NSTEMI, undergoing PCI using the EluNIR stent.
3. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.

In addition, patients must meet at least one of the following criteria for high risk of bleeding:

1. Age ≥75 years
2. Oral anticoagulation planned to continue after PCI
3. Hemoglobin \<11 g/liter or anemia requiring transfusion within 12 weeks before enrollment to the study
4. Platelet count\< 100,000/mm³
5. Hospital admission for bleeding in previous 12 months
6. Stroke in previous 12 months
7. Previous intracerebral hemorrhage
8. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
9. Renal failure defined as creatinine clearance\< 40 ml/min
10. Non-skin cancer diagnosed or treated \< 3 years
11. Planned surgery within 12 months that would require interruption of DAPT
12. Planned daily NSAID (other than aspirin) or steroids for \> 30 days after PCI
13. Expected nonadherence to \>30 days of dual antiplatelet therapy in stable patients and \>3 months in ACS patients

Angiographic inclusion criteria (visual estimate)

1. Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), presence of thrombus that is non-occlusive and does not require thrombectomy, CTO, bifurcation lesions (except planned dual stent implantation), ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions, and saphenous vein graft lesions.
2. Up to 2 overlapping stents are allowed (ie, one overlap)

Exclusion Criteria:

All exclusion criteria must be absent for the patient to be eligible for enrollment.

General Exclusion Criteria

1. Pregnant and breastfeeding women
2. Patients requiring a planned staged PCI with a non-study stent
3. Patients expected not to comply with 1-month DAPT.
4. Patients expected not to comply with long-term single anti-platelet therapy
5. PCI during the previous 12 months with a non-study stent
6. History of stent thrombosis
7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
8. Subject is intubated.
9. Known LVEF \<30%.
10. White blood cell (WBC) count \<3,000 cells/mm3.
11. Active bleeding from any site at time of inclusion
12. Known allergy to protocol-required concomitant medications such as aspirin, or DAPT (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated.
13. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduced life expectancy to \<12 months (e.g. cancer, severe heart failure, severe lung disease).
14. Patient has received an organ transplant or is on a waiting list for an organ transplant.
15. Participation in another clinical trial that has not reached its primary endpoint.

Angiographic Exclusion Criteria (visual estimate)

1. Visually estimated RVD\<2.5 mm or \>4.25mm.
2. Unprotected left main intervention.
3. Ostial LAD and/or LCx intervention
4. Bifurcation lesions with dual stent implantation.
5. Stenting of lesions due to DES restenosis.
6. Total stented length \> 60 mm
7. Planned implantation of any DES which is not EluNIR

Note: In case the procedure required the unplanned implantation of a different (non-EluNIR) stent the subject will be de-registered from the study.

Primary outcomes:
measure: The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable)
timeFrame: 1 Year
Secondary outcomes:
measure: TLF, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR)
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: The composite of cardiac death, myocardial infarction, or stent thrombosis at 30 days and 6 months
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: All-cause mortality
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Cardiac death
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Bleeding events according to BARC definitions
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Myocardial Infarction
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Target Vessel Related MI
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Ischemia-driven TLR
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Ischemia-driven TVR
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Stent Thrombosis (ARC definite and probable)
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
measure: Bleeding complications (BARC definitions), evaluated as components and as a composite of BARC Type 3 and 5 bleeding
timeFrame: To be evaluated at 30 days, 6 months, and 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Medinol LTD
Study officials:
References: