Trials / Unknown
UnknownNCT03719014
Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Nitiloop Ltd. · Industry
- Sex
- All
- Age
- 25 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NovaCross | The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization. |
Timeline
- Start date
- 2018-11-01
- Primary completion
- 2019-04-01
- Completion
- 2019-12-01
- First posted
- 2018-10-25
- Last updated
- 2018-11-06
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03719014. Inclusion in this directory is not an endorsement.