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

NCT03877848 | Completed DMC FDA Device

• 1 other identifier: EluNIR HBR study
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Stenosis

Keywords

bleeding; PCI

Outcome Measures

Primary Outcomes (1)

• The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable)

  1 Year

Secondary Outcomes (13)

• TLF, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.

  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)

  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)

  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

  To be evaluated at 30 days, 6 months, and 1 year

• All-cause mortality

  To be evaluated at 30 days, 6 months, and 1 year

Study Arms (1)

ACS and Non-ACS

DAPT will be stopped at 30 days in non-ACS subjects while at ACS Patients it may be maintained for up to 3 months. In patients with ACS or with an ischemic event during the first 30 days, DAPT may be continued at the discretion of the investigator. In ACS patients DAPT should be continued for a maximum of 3 months. For patients with recurrent ischemic events duration of DAPT therapy will be at the discretion of the investigator. Patients receiving long-term oral anticoagulation with either a Vitamin K inhibitor or a NOAC/DOAC will receive either single antiplatelet therapy with clopidogrel, or DAPT for 30 days (triple therapy) followed by single antiplatelet therapy with clopidogrel. Clopidogrel (75 mg QD) will be given to these patients post procedure for 6 months in stable patients and 12 months in ACS patients.

Device: Percutaneous Coronary Intervention (PCI)

Interventions

Percutaneous Coronary Intervention (PCI) DEVICE

Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines.

ACS and Non-ACS

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

High bleeding risk subjects undergoing PCI using the EluNIR stent for angina, silent ischemia or non STEMI.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Visually estimated RVD\<2.5 mm or \>4.25mm.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (1)

Medinol LTD

Tel Aviv, Israel

Location

Related Publications (1)

• Kornowski R, Konigstein M, Jonas M, Assali A, Vaknin-Assa H, Segev A, Danenberg H, Halabi M, Roguin A, Kerner A, Lev E, Karamasis GV, Johnson TW, Anderson R, Blaxill J, Jadhav S, Hoole S, Witberg G, Issever MO, Ben-Yehuda O, Baumbach A. Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk. J Am Heart Assoc. 2024 Jan 16;13(2):e029051. doi: 10.1161/JAHA.122.029051. Epub 2024 Jan 12.

  PMID: 38214256 DERIVED

MeSH Terms

Conditions

Coronary Stenosis; Hemorrhage

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: May 6, 2019
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)