Trial Outcomes & Findings for BIONICS Israel Trial (NCT NCT02834806)

NCT ID: NCT02834806

Last Updated: 2020-09-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: during baseline procedure
• Results posted on: 2020-09-24

Participant Flow

Participant milestones

Measure	BioNIR Drug Eluting Stent System BioNIR Ridaforolimus eluting coronary stent system with modified delivery system BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BIONICS Israel Trial

Baseline characteristics by cohort

Measure	BioNIR Drug Eluting Stent System n=58 Participants BioNIR Ridaforolimus eluting coronary stent system with modified delivery system BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	49 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	58 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	58 participants n=5 Participants

PRIMARY outcome

Timeframe: during baseline procedure

Outcome measures

Measure	BioNIR Drug Eluting Stent System n=58 Participants BioNIR Ridaforolimus eluting coronary stent system with modified delivery system BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
Device Success in the Target Lesion as Determined by the Angiographic Core Laboratory	58 Participants

SECONDARY outcome

Timeframe: during baseline procedure

Lesion success is defined as achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during baseline procedure

Procedure success is defined as achievement of a final in-stent diameter stenosis of <50% (by QCA) using the assigned device and/or with any adjunctive devices, without the occurrence of cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Clinical follow-up will be performed at 30 days.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Telephone follow up will be performed at 6 months post procedure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Telephone follow up will be performed at 1 year post procedure

Outcome measures

Outcome data not reported

Adverse Events

BioNIR Drug Eluting Stent System

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	BioNIR Drug Eluting Stent System n=58 participants at risk BioNIR Ridaforolimus eluting coronary stent system with modified delivery system BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
Cardiac disorders Peri procedureal MI	3.4% 2/58 • 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.
Cardiac disorders Non specific chest pain	1.7% 1/58 • 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.

Other adverse events

Measure	BioNIR Drug Eluting Stent System n=58 participants at risk BioNIR Ridaforolimus eluting coronary stent system with modified delivery system BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
Infections and infestations Viral Infection	1.7% 1/58 • 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.
General disorders General disorders and administration site conditions	10.3% 6/58 • 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.
Cardiac disorders Cardiac disorders	10.3% 6/58 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	3.4% 2/58 • 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.
Eye disorders eye disorders	1.7% 1/58 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	5.2% 3/58 • 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.

Additional Information

Dina Kofler, VP Clinical Affairs

Medinol

Phone: +97237679032

Email: dinak@medinol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place