Clinical Trials

Broad Clinical Program

IoNIR - IonMAN

Prospective, multi-center, single arm, open label clinical trial.

enrol

Enrollment

Completed

world

4 Sites

Brazil, Israel
patients

60 Patients

TLF

Primary Endpoints

1. In-stent Late Loss at 13 months
2. TLF at 12 months.

EluNIR – HBR

Prospective, multi-center, open-label, single arm, post marketing clinical trial

enrol

Study

Completed

world

18 Sites

UK, Israel
patients

316 Patients

TLF

Primary Endpoint

TLF at 12 months: 4.9%
The composite of cardiac death, MI, or ST (ARC definite and probable).

EluNIR – JNIR

Prospective, multi-center, open-label, single arm clinical trial

enrol

Study

Completed

world

10 Sites

Japan
patients

104 Patients

TLF

Primary Endpoint

TLF at 12 months: 1.9%
ST (definite/probable) at 12 months: 0.0%

EluNIR – BIONICS

Prospective, multi-center, single-blind, two-arm, randomized clinical trial

enrol

Study

Completed

world

76 Sites

USA, Canada, Europe, Israel
patients

1,919 Patients

EluNIR | n=958 Resolute | n=961
TLF

Primary Endpoint

TLF at 12 months

Target Lesion Failure 12 Months

p = 0.0013 (for non-inferiority)
TLF 12M

Stent Thrombosis 24 Months

ST 24M p
Dr. David Kandzari, MD
EluNIR clinical program
Watch Video
Dr. Alaide Chieffo, MD
1yr BIONICS trial outcomes
Watch Video

EluNIR – NIREUS

Prospective, multi-center, single-blind, two-arm, randomized clinical trial

enrol

Study

Completed

world

31 Sites

Europe, Israel
patients

302 Patients

EluNIR | n=201 Resolute | n=101
TLF

Primary endpoint

In-stent late loss at 6 months

In Stent Late-Loss

6 Months

In Stent 6M

Target Lesion Failure/Mace

12 Months

TLF Mace 12M
Dr. David Kandzari, MD
EluNIR clinical program
Watch Video

EluNIR - BIONICS Small Vessels

Prospective, multi-center, single arm, open label clinical trial.

enrol

Study

Completed

world

 9 Sites

Israel
patients

81 Patients

TLF

Primary Endpoints

1. MACE at 30 days: 1.2%
2. TLF at 6 months (evaluated for the first 50% of patients enrolled): 2.4%

EluNIR - BIONICS Long Lesions

Prospective, multi-center, single-arm, open-label clinical trial

enrol

Study

Completed

world

6 Sites

Israel
patients

50 Patients

TLF

Primary endpoint

Device success as determined by the Angiographic Core Lab (ACL) with no MACE at 30 days: 88%

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