Trials / Completed
CompletedNCT03717675
Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Nitiloop Ltd. · Industry
- Sex
- All
- Age
- 25 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.
Detailed description
The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NovaCross™ Chronic Total Occlusion micro-catheter | The NovaCross™ micro catheter is a guidewire positioning and support micro catheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment. Investigators will use the NovaCross Micro catheter during a standard of care catheterization of patients diagnosed with coronary total occlusion. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2019-07-17
- Completion
- 2019-11-01
- First posted
- 2018-10-24
- Last updated
- 2019-12-03
Locations
3 sites across 3 countries: Israel, Poland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03717675. Inclusion in this directory is not an endorsement.