Study of BioNIR Drug Eluting Stent System in Coronary Stenosis (BIONICS)
Coronary Artery Stenosis
About this trial
This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring more comers, DES, BioNIR, ACS, non ACS, complex lesions
Eligibility Criteria
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 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
- Patient receiving/scheduled to receive chemotherapy within 30 days before/any time after the baseline procedure
- Patient receiving oral/intravenous immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease (e.g. HIV); corticosteroids are allowed
- More than 100mm length of planned stenting in the entire coronary tree
- Unprotected left main lesions ≥30%, or planned left main intervention
- Ostial LAD/LCX lesions (stenting of any diseased segment within 5mm of the unprotected left main coronary artery)
- Bifurcation lesions with planned dual stent implantation
- Stenting of lesions due to DES restenosis
- Another lesion in a target/non-target vessel (including all side branches) is present that requires/has high probability of requiring PCI within 12 months after baseline procedure
Sites / Locations
- Piedmont Healthcare
- ZNA Middelheim
- Queen Elizabeth II Health Sciences Centre
- Hadassah Hebrew University Medical Center
- San Raffaele Hospital
- Maasstad Ziekenhuis
- PAKS, II Oddzial Kardiologiczny
- Hospital Meixoeiro
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BioNIR
Resolute
The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: Stent - a mounted Cobalt Chromium (CoCr) alloy based stent Delivery System - Rapid Exchange (RX) Coronary System Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).
The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems: Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent Delivery system (Rapid Exchange [RX] Coronary System) Polymer system Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area.