Study of BioNIR Drug Eluting Stent System in Coronary Stenosis (NCT01995487) | Clinical Trial Compass
CompletedNot Applicable
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
United States, Belgium, Canada1,919 participantsStarted 2014-01
Plain-language summary
The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient with indication for PCI including angina/silent ischemia/NSTEMI/recent STEMI
* Non-target vessel PCI allowed prior to randomization depending on time interval and certain conditions
* Patient/legal guardian willing \& able to provide informed written consent \& comply with follow-up visits \& testing schedule
* Target lesion(s) must be located in native coronary artery/bypass graft conduit w/visually estimated diameter ≥2.5mm to ≤4.25mm.
* Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as per exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft
Exclusion Criteria:
* STEMI within 24 hours of init. time of presentation to first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked
* PCI within 24 hours preceding baseline procedure
* Non-target lesion PCI in target vessel within 12 months of baseline procedure
* History of stent thrombosis
* Cardiogenic shock (persistent hypotension \[systolic blood pressure \<90mm/Hg for MT 30 min\] or requiring pressors/hemodynamic support, including IABP)
* Subject is intubated
* Known LVEF \<30%
* Relative/absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject indicated for chronic oral anticoagulant treatment)
* Calculated creatinine clearance \<30 mL/min per Cockcroft-Gault equation (\<40mL/min for subject…