NL-OMON47650
Completed
Not Applicable
BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial - BIONICS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- coronary artery disease
- Sponsor
- Medinol Ltd.
- Enrollment
- 119
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \* 18 years.
- •2\. 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 randomization and enzyme levels (CK\-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
- •3\. Non\-target vessel PCI are allowed prior to randomization depending on the time interval as follows:
- •a. During Baseline Procedure:
- •i. PCI of non\-target vessels performed during the baseline procedure itself immediately prior to randomization 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.
- •b. Less than 24 hours prior to Baseline Procedure:
- •i. Not allowed (see exclusion criteria \#2\).
- •c. 24 hours\-30 days prior to Baseline Procedure:
- •i. PCI of non\-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above.
- •ii. In addition, in cases where non\-target lesion PCI has occurred 24\-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non\-target vessel PCI.
Exclusion Criteria
- •1\. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or patients in whom enzyme levels (either CK\-MB or Troponin) have not peaked.
- •2\. PCI within the 24 hours preceding the baseline procedure.
- •3\. Non\-target lesion PCI in the target vessel within 12 months of the baseline procedure.
- •4\. History of stent thrombosis.
- •5\. 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.
- •6\. Subject is intubated.
- •7\. Known LVEF \<30%.
- •8\. Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or on or indicated for chronic oral anticoagulant treatment).
- •9\. Calculated creatinine clearance \<30 mL/min using Cockcroft\-Gault equation (\<40 mL/min for subjects participating in the angiographic follow\-up sub\-study).
- •10\. Hemoglobin \<10 g/dL.
Outcomes
Primary Outcomes
Not specified
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