Status:
COMPLETED
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
Lead Sponsor:
Medinol Ltd.
Conditions:
Coronary Stenosis
Eligibility:
All Genders
18-120 years
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 wi...
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 st...
Eligibility Criteria
Inclusion
- All inclusion criteria must be present for the patient to be eligible for enrollment.
- General Inclusion Criteria
- Age ≥ 18 years.
- Patient with angina (stable or unstable), silent ischemia or NSTEMI, undergoing PCI using the EluNIR stent.
- 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:
- Age ≥75 years
- Oral anticoagulation planned to continue after PCI
- Hemoglobin \<11 g/liter or anemia requiring transfusion within 12 weeks before enrollment to the study
- Platelet count\< 100,000/mm³
- Hospital admission for bleeding in previous 12 months
- Stroke in previous 12 months
- Previous intracerebral hemorrhage
- Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
- Renal failure defined as creatinine clearance\< 40 ml/min
- Non-skin cancer diagnosed or treated \< 3 years
- Planned surgery within 12 months that would require interruption of DAPT
- Planned daily NSAID (other than aspirin) or steroids for \> 30 days after PCI
- Expected nonadherence to \>30 days of dual antiplatelet therapy in stable patients and \>3 months in ACS patients
- Angiographic inclusion criteria (visual estimate)
- 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.
- Up to 2 overlapping stents are allowed (ie, one overlap)
Exclusion
- All exclusion criteria must be absent for the patient to be eligible for enrollment.
- General Exclusion Criteria
- Pregnant and breastfeeding women
- Patients requiring a planned staged PCI with a non-study stent
- Patients expected not to comply with 1-month DAPT.
- Patients expected not to comply with long-term single anti-platelet therapy
- PCI during the previous 12 months with a non-study stent
- History of stent thrombosis
- 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.
- Subject is intubated.
- Known LVEF \<30%.
- White blood cell (WBC) count \<3,000 cells/mm3.
- Active bleeding from any site at time of inclusion
- 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.
- 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).
- Patient has received an organ transplant or is on a waiting list for an organ transplant.
- Participation in another clinical trial that has not reached its primary endpoint.
- Angiographic Exclusion Criteria (visual estimate)
- Visually estimated RVD\<2.5 mm or \>4.25mm.
- Unprotected left main intervention.
- Ostial LAD and/or LCx intervention
- Bifurcation lesions with dual stent implantation.
- Stenting of lesions due to DES restenosis.
- Total stented length \> 60 mm
- 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.
Key Trial Info
Start Date :
May 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT03877848
Start Date
May 6 2019
End Date
June 10 2021
Last Update
September 1 2021
Active Locations (1)
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1
Medinol LTD
Tel Aviv, Israel