NL-OMON47919
Completed
Not Applicable
BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) European Angiography Study - NIREUS
Medinol Lid.0 sites49 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- coronary artery disease
- Sponsor
- Medinol Lid.
- Enrollment
- 49
- 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 and conditions 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 \#3\).
- •c. 24 hours\-30 days prior to Baseline Procedure:
Exclusion Criteria
- •1\. Planned procedures after the baseline procedure in either the target or non\-target vessels.
- •2\. 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.
- •3\. PCI within the 24 hours preceding the baseline procedure and randomization.
- •4\. Non\-target lesion PCI in the target vessel within 12 months of the baseline procedure.
- •5\. History of stent thrombosis.
- •6\. 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.
- •7\. Known LVEF \<30%.
- •8\. Subject is intubated.
- •9\. Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment).
Outcomes
Primary Outcomes
Not specified
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