COMPANY
InfraReDx
FDA-cleared device company Past trials only
Timeline
- FDA FDA 510(k) clearance: Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) — K241576, 2025-02-2 source ↗
- Trial start Not phased (device or behavioral study): A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon source ↗
- Trial start Not phased (device or behavioral study): In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems source ↗
- Trial start —: The Lipid-Rich Plaque Study source ↗
- Trial start Not phased (device or behavioral study): CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow source ↗
- Trial start Phase 4: Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study source ↗
- Trial start —: Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter source ↗
- Trial start —: An Observational Study of Cholesterol in Coronary Arteries source ↗
- Trial start Phase 2/Phase 3: SPECTACL: SPECTroscopic Assessment of Coronary Lipid source ↗
Clinical trials (lead sponsor) 8
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04985773 | A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon | Not phased (device or behavioral study) | Completed | Dec 17, 2021 | Dec 16, 2022 (actual) |
| NCT00330928 | SPECTACL: SPECTroscopic Assessment of Coronary Lipid | Phase 2/Phase 3 | Completed | 2006-01 | 2007-10 (actual) |
| NCT02154295 | In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems | Not phased (device or behavioral study) | Completed | 2014-05 | 2014-08 (actual) |
| NCT02033694 | The Lipid-Rich Plaque Study | Not listed | Completed | 2014-02 | 2018-04 (actual) |
| NCT01268319 | CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow | Not phased (device or behavioral study) | Terminated | 2011-05 | 2014-09 (actual) |
| NCT00831116 | An Observational Study of Cholesterol in Coronary Arteries | Not listed | Completed | 2009-02 | 2016-02 (actual) |
| NCT00905671 | Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study | Phase 4 | Completed | 2009-06 | 2011-08 (actual) |
| NCT00901446 | Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter | Not listed | Completed | 2009-05 | 2010-05 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) — K241576, Feb 26, 2025. Applicant at approval: Infraredx, Inc. source ↗
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