N/A
Completed N=1,919
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
Source: ClinicalTrials.gov NCT01995487 ↗Enrolled (actual)
1,919
Serious AEs
25.8%
Results posted
Feb 2021
Primary outcomePrimary: Target Lesion Failure (TLF) — 5.4; 5.4 percentage of TLF
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Lesion Failure (TLF) |
5.4; 5.4 | — |
| SECONDARY Device Success |
— | — |
| SECONDARY TLF |
— | — |
| SECONDARY Major Adverse Cardiac Events |
— | — |
| SECONDARY Target Vessel Failure |
— | — |
| SECONDARY All Cause Mortality |
— | — |
| SECONDARY Cardiac Death |
— | — |
| SECONDARY Myocardial Infarction |
— | — |
| SECONDARY Target Vessel Related MI |
— | — |
| SECONDARY Ischemia Driven TLR |
— | — |
| SECONDARY Ischemia Driven TVR |
— | — |
| SECONDARY Stent Thrombosis |
— | — |
| SECONDARY Angiographic Sub-Study: In-stent and In-segment Late Loss |
— | — |
| SECONDARY IVUS Sub-Study: In-stent Percent Neointimal Hyperplasia |
— | — |
| SECONDARY IVUS Sub-Study: Stent Mal-apposition |
— | — |
| SECONDARY Lesion Success |
— | — |
| SECONDARY Procedure Success |
— | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01995487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.