EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study

About this trial

Last updated 5 years ago

Study ID

EluNIR HBR study

Status

Completed

Type

Observational

Placebo

Accepting

18 to 120 Years

All Sexes

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

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.