BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Stenosis
- Sponsor
- Medinol Ltd.
- Enrollment
- 81
- Locations
- 9
- Primary Endpoint
- MACE
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Device:
EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length)
Objectives:
To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR.
Subject Population:
Subjects who underwent PCI for angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, and recent STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.
Trial Design and Methods:
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years.
- •Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>24 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
- •An attempt (whether successful or not) was made to implant a 2.25 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
- •Non-target lesion PCIs are allowed depending on the time interval and conditions as follows:
- •During Index Procedure:
- •if successful and uncomplicated defined as: \<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.
- •Less than 24 hours prior to Index Procedure:
- •Not allowed (see exclusion criteria #2). c. 24 hours-30 days prior to Index Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to the index procedure if successful and uncomplicated as defined above.
- •ii. In addition, in cases where non-target vessel PCI has occurred 24-72 hours prior to the index procedure, at least 2 sets of cardiac biomarkers must have been drawn at least 6 and 12 hours after the non-target vessel PCI.
- •iii. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.
Exclusion Criteria
- •STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin) have not peaked.
- •PCI within the 24 hours preceding the index procedure.
- •Non-target lesion PCI in the target vessel 24 hours to 30 days.
- •Planned staged procedures.
- •Brachytherapy in conjunction with the index procedure.
- •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%.
- •Relative or absolute contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment).
Outcomes
Primary Outcomes
MACE
Time Frame: At 30 days
Combined early efficacy and safety endpoint: MACE at 30 days for all patients enrolled. MACE is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.
TLF
Time Frame: At 6 month
Combined late efficacy and safety endpoint: Target Lesion Failure (TLF) at 6 months (evaluated for the first 50% of patients enrolled) Defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
Secondary Outcomes
- Lesion success(30 Days, 6 Months & 1Year)
- Ischemia-driven TVR(30 Days, 6 Months & 1Year)
- Target vessel failure(30 Days, 6 Months & 1 Year)
- TLF(6 Months and 1 Year)
- Procedure success(30 Days, 6 Months & 1Year)
- Device success(30 Days, 6 Months & 1 Year)
- Ischemia-driven TLR(30 Days, 6 Months & 1 Year)
- All-cause mortality(30 Days, 6 Months & 1 Year)
- Stent thrombosis(30 Days, 6Months & 1Year)
- Major adverse cardiac events(30 Days, 6 Months & 1Year)
- Cardiac death(30 Days, 6 Months & 1Year)
- MI(30 Days, 6 Months & 1Year)
- Target vessel related MI(30 Days, 6 Months & 1 Year)