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NIRTRAKS Post-Market Study (NIRTRAKS)
NA trial testing Stenting procedure in de Novo Stenotic Lesions in Native Coronary Arteries in 65 participants. Completed in 14 January 2020.
| Lead sponsor | Medinol Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 8 January 2016 |
| Primary completion | 14 January 2020 |
| Estimated completion | 14 January 2020 |
| Sites | 1 location across United States |
Medinol Ltd.
18 and older, any sex, with de Novo Stenotic Lesions in Native Coronary Arteries. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Single Arm | 15 | 14.5 – 37.3 |
Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Single Arm |
|---|---|---|
| cardiac disorders | Cardiac disorders | — |
| General disorders and administration site conditions | Gastrointestinal disorders | — |
| General disorders and administration site conditions | General disorders | — |
| Infections and infestations | Infections and infestations | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — |
| renal and urinary disorders | Renal and urinary disorders | — |
| neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Vascular disorders | Vascular disorders | — |
| metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — |
| ear and labyrinth disorders | Ear and labyrinth disorders | — |
| Eye disorders | Eye disorders | — |
| hepatobiliary disorders | Hepatobiliary disorders | — |
| Investigations | Investigations | — |
| nervous system disorders | Nervous system disorders | — |
| psychiatric disorders | Product Issues | — |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — |
| Reaction | System | Single Arm |
|---|---|---|
| Cardiac Disorders | Cardiac disorders | — |
| General disorders and administration site conditions | General disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Infections and infestations | Infections and infestations | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Vascular disorders | Vascular disorders | — |
| nervous system disorders | Nervous system disorders | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — |
| musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — |
| renal and urinary disorders | Renal and urinary disorders | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — |
| Investigations | Investigations | — |
| metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| psychiatric disorders | Psychiatric disorders | — |
| ear and labyrinth disorders | Eye disorders | — |
| Eye disorders | Eye disorders | — |
| hepatobiliary disorders | Hepatobiliary disorders | — |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: cardiac disorders, General disorders and administration site conditions, General disorders and administration site conditions, Infections and infestations, Respiratory, thoracic and mediastinal disorders, Injury, poisoning and procedural complications, renal and urinary disorders, neoplasms benign, malignant and unspecified.
Data from ClinicalTrials.gov NCT02455804 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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