Trial Outcomes & Findings for MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR) (NCT NCT02828917)

Results Overview

TLF is defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	MedJ-01 Drug Eluting Stent MedJ-01 Ridaforolimus eluting coronary stent system MedJ-01 Ridaforolimus Eluting Coronary Stent System
Overall Study STARTED	104
Overall Study COMPLETED	104
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MedJ-01 Drug Eluting Stent n=104 Participants MedJ-01 Ridaforolimus eluting coronary stent system MedJ-01 Ridaforolimus Eluting Coronary Stent System
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	77 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	104 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	0 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 Japan	104 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

TLF is defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.

Outcome measures

Outcome measures
Measure	MedJ-01 Drug Eluting Stent n=104 Participants MedJ-01 Ridaforolimus eluting coronary stent system MedJ-01 Ridaforolimus Eluting Coronary Stent System
Target Lesion Failure (TLF)	2 Participants

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Device Success at time of baseline procedure- outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Lesion Success at time of baseline procedure- outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Procedure Success at time of baseline procedure- outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 2, 3, 4 and 5 years

TLF- target lesion failure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

MACE is the composite rate of cardiac death, any MI or ischemia-driven TLR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

the composite rate of death, target vessel related MI or ischemia-driven TVR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

All-cause mortality outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Cardiac Death outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Myocardial Infarction (MI)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Target Vessel Related MI outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Ischemia-driven TLR outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Ischemia-driven TVR outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

ARC definite and probable

Outcome measures

Outcome data not reported

Adverse Events

MedJ-01 Drug Eluting Stent

Serious events: 21 serious events

Other events: 59 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	MedJ-01 Drug Eluting Stent n=104 participants at risk MedJ-01 Ridaforolimus eluting coronary stent system MedJ-01 Ridaforolimus Eluting Coronary Stent System
Cardiac disorders cardiac disorders	6.7% 7/104 • Number of events 7 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Eye disorders Eye disorders	1.9% 2/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Gastrointestinal disorders Gastrointestinal disorders	6.7% 7/104 • Number of events 8 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
General disorders General disorders and administration site conditions	2.9% 3/104 • Number of events 3 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	1.9% 2/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	1.9% 2/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Renal and urinary disorders Renal and urinary disorders	0.96% 1/104 • Number of events 1 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.96% 1/104 • Number of events 1 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Vascular disorders Vascular disorders	0.96% 1/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.

Other adverse events

Other adverse events
Measure	MedJ-01 Drug Eluting Stent n=104 participants at risk MedJ-01 Ridaforolimus eluting coronary stent system MedJ-01 Ridaforolimus Eluting Coronary Stent System
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.9% 2/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Cardiac disorders Cardiac Disorders	14.4% 15/104 • Number of events 15 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Eye disorders Eye disorders	2.9% 3/104 • Number of events 4 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Gastrointestinal disorders Gastrointestinal disorders	13.5% 14/104 • Number of events 20 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
General disorders General disorders and administration site conditions	11.5% 12/104 • Number of events 14 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Hepatobiliary disorders Hepatobiliary disorders	0.96% 1/104 • Number of events 1 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Infections and infestations Infections and infestations	16.3% 17/104 • Number of events 20 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	10.6% 11/104 • Number of events 13 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Investigations Investigations	1.9% 2/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Metabolism and nutrition disorders Metabolism and nutrition disorders	1.9% 2/104 • Number of events 2 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	4.8% 5/104 • Number of events 5 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	2.9% 3/104 • Number of events 5 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Nervous system disorders Nervous system disorders	7.7% 8/104 • Number of events 8 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Psychiatric disorders Psychiatric disorders	0.96% 1/104 • Number of events 1 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Renal and urinary disorders Renal and urinary disorders	2.9% 3/104 • Number of events 4 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	3.8% 4/104 • Number of events 4 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	11.5% 12/104 • Number of events 12 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.
Vascular disorders Vascular disorders	4.8% 5/104 • Number of events 8 • The Investigator monitored the occurrence of adverse events or device deficiencies for each subject during the whole course of the trial, visits: baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.

Additional Information

Dina Kofler, VP Clinical Affairs

Medinol

Phone: +97237679032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place