Trial Outcomes & Findings for BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial (NCT NCT03702608)
NCT ID: NCT03702608
Last Updated: 2020-10-28
Results Overview
Device success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only and without a device malfunction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 day
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
EluNIR 38mm
Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
* Delivery System - Rapid Exchange (RX) Coronary System
* Polymer matrix coating - (PBMA) and CarboSil®
* Ridaforolimus drug
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial
Baseline characteristics by cohort
| Measure |
EluNIR 38mm
n=50 Participants
Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
* Delivery System - Rapid Exchange (RX) Coronary System
* Polymer matrix coating - (PBMA) and CarboSil®
* Ridaforolimus drug
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 dayDevice success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only and without a device malfunction.
Outcome measures
| Measure |
EluNIR 38mm
n=50 Participants
EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
* Delivery System - Rapid Exchange (RX) Coronary System
* Polymer matrix coating - (PBMA) and CarboSil®
* Ridaforolimus drug
|
|---|---|
|
Primary Endpoint: Device Success
|
44 Participants
|
PRIMARY outcome
Timeframe: 30 DayNo 30 day MACE: MACE (Major Adverse Cardiac Events) is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.
Outcome measures
| Measure |
EluNIR 38mm
n=50 Participants
EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
* Delivery System - Rapid Exchange (RX) Coronary System
* Polymer matrix coating - (PBMA) and CarboSil®
* Ridaforolimus drug
|
|---|---|
|
Primary Endpoint: No 30 Day MACE (Major Adverse Cardiac Events)
|
44 Participants
|
Adverse Events
EluNIR 38mm
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EluNIR 38mm
n=49 participants at risk
Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
* Delivery System - Rapid Exchange (RX) Coronary System
* Polymer matrix coating - (PBMA) and CarboSil®
* Ridaforolimus drug
|
|---|---|
|
General disorders
General disorders and administration site conditions
|
4.1%
2/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Infections and infestations
Infections and infestations
|
4.1%
2/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Cardiac disorders
Cardiac disorders
|
8.2%
4/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Vascular disorders
Vascular disorders
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
Other adverse events
| Measure |
EluNIR 38mm
n=49 participants at risk
Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
* Delivery System - Rapid Exchange (RX) Coronary System
* Polymer matrix coating - (PBMA) and CarboSil®
* Ridaforolimus drug
|
|---|---|
|
Cardiac disorders
Cardiac disorders
|
14.3%
7/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
General disorders
General disorders and administration site conditions
|
8.2%
4/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Infections and infestations
Infections and infestations
|
6.1%
3/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Investigations
Investigations
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Psychiatric disorders
Psychiatric disorders
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
6.1%
3/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
2.0%
1/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
|
Vascular disorders
Vascular disorders
|
6.1%
3/49 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial- baseline and post procedure, 30 days, 6 months and 1 year visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place