Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

Completed · Not applicable

Conditions studied: Coronary Artery Stenosis

In brief

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.

Key facts

Study ID

NCT01995487

Run by

Medinol Ltd.

People needed

1919

Starts

2014-01-01

Expected to finish

2020-11-30

Last updated by the study team

2023-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 subjects participating in angiographic follow-up sub-study)
• Hemoglobin <10g/dL
• Platelet count <100,000 cells/mm3 or >700,000 cells/mm3
• White blood cell (WBC) count <3,000 cells/mm3
• Clinically significant liver disease
• Active peptic ulcer/active bleeding from any site
• Bleeding from any site within prior 8 wks requiring active medical/surgical attention
• If femoral access is planned, significant peripheral arterial disease that precludes safe insertion of 6F sheath
• History of bleeding diathesis/coagulopathy/will refuse blood transfusions
• Cerebrovascular accident/transient ischemic attack within past 6 months, or any permanent neurologic defect attributed to CVA
• Known allergy to study stent components, BioNIR or Resolute
• Known allergy to protocol-required concomitant medications: aspirin/DAPT (clopidogrel, prasugrel, ticagrelor)/heparin and bivalirudin/iodinated contrast that cannot be adequately pre-medicated
• Any co-morbid condition that may cause non-compliance with protocol (e.g. dementia, substance abuse) /reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease)
• Patient participating/plans to participate in another investigational drug/device clinical trial that has not reached its primary endpoint
• Pregnant/breastfeeding women (women of child-bearing potential must have a negative pregnancy test within 1 wk before treatment)
• Women who intend to become pregnant within 12 months after baseline procedure (sexually active women of child-bearing potential must agree to use a reliable method of contraception from time of screening through 12 months post baseline procedure)
• Patient has received/is on a waiting list for an organ transplant

Where it is running

• Piedmont Healthcare — Atlanta, Georgia, United States
• ZNA Middelheim — Antwerp, Belgium
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Hadassah Hebrew University Medical Center — Jerusalem, Israel
• San Raffaele Hospital — Milan, Italy
• Maasstad Ziekenhuis — Rotterdam, Netherlands
• PAKS, II Oddzial Kardiologiczny — Bielsko-Biala, Poland
• Hospital Meixoeiro — Pontevedra, VIGO, Spain

Full record on ClinicalTrials.gov

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