Trial Outcomes & Findings for NIRTRAKS Post-Market Study (NIRTRAKS) (NCT NCT02455804)

Last Updated: 2023-10-04

Results Overview

The primary endpoint in this study was TVF (Target Vessel Failure) defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

3 years

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Overall Study STARTED	65
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NIRTRAKS Post-Market Study (NIRTRAKS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=65 Participants This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Age, Continuous	68.06 years STANDARD_DEVIATION 10.10 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 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	4 Participants n=5 Participants
Race (NIH/OMB) White	60 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 United States	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Single Arm n=61 Participants This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Target Vessel Failure	15 percentage of TVF Interval 14.5 to 37.3

Adverse Events

Single Arm

Serious events: 40 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=65 participants at risk This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Cardiac disorders cardiac disorders	44.6% 29/65 • Number of events 43 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Ear and labyrinth disorders ear and labyrinth disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Eye disorders Eye disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Gastrointestinal disorders General disorders and administration site conditions	12.3% 8/65 • Number of events 10 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
General disorders General disorders and administration site conditions	9.2% 6/65 • Number of events 7 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Hepatobiliary disorders hepatobiliary disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Infections and infestations Infections and infestations	9.2% 6/65 • Number of events 8 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	7.7% 5/65 • Number of events 8 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Investigations Investigations	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Metabolism and nutrition disorders metabolism and nutrition disorders	3.1% 2/65 • Number of events 3 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorders	3.1% 2/65 • Number of events 4 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benign, malignant and unspecified	4.6% 3/65 • Number of events 3 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Nervous system disorders nervous system disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Product Issues psychiatric disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Renal and urinary disorders renal and urinary disorders	7.7% 5/65 • Number of events 5 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	9.2% 6/65 • Number of events 6 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Vascular disorders Vascular disorders	4.6% 3/65 • Number of events 3 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.

Other adverse events

Other adverse events
Measure	Single Arm n=65 participants at risk This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted. Stenting procedure: All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Blood and lymphatic system disorders Blood and lymphatic system disorders	7.7% 5/65 • Number of events 5 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Cardiac disorders Cardiac Disorders	56.9% 37/65 • Number of events 69 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Eye disorders ear and labyrinth disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Eye disorders Eye disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Gastrointestinal disorders Gastrointestinal disorders	18.5% 12/65 • Number of events 17 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
General disorders General disorders and administration site conditions	32.3% 21/65 • Number of events 31 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Hepatobiliary disorders hepatobiliary disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Infections and infestations Infections and infestations	21.5% 14/65 • Number of events 17 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	10.8% 7/65 • Number of events 10 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Investigations Investigations	7.7% 5/65 • Number of events 5 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Metabolism and nutrition disorders metabolism and nutrition disorders	6.2% 4/65 • Number of events 5 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorders	10.8% 7/65 • Number of events 11 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benign, malignant and unspecified	6.2% 4/65 • Number of events 5 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Nervous system disorders nervous system disorders	13.8% 9/65 • Number of events 10 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Psychiatric disorders psychiatric disorders	3.1% 2/65 • Number of events 2 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Renal and urinary disorders renal and urinary disorders	9.2% 6/65 • Number of events 6 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	29.2% 19/65 • Number of events 28 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	1.5% 1/65 • Number of events 1 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.
Vascular disorders Vascular disorders	16.9% 11/65 • Number of events 14 • Adverse events occurring (1) from time of index procedure to 30 days follow-up contact, (2) From 30 days follow up contact to 1 year follow-up contact, (3) From 1 year follow-up contact to 2 years follow-up contact, and (4) From 2 years follow-up contact to 3 years follow-up contact, were recorded.

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