Trials / Completed
CompletedNCT03403426
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- ReFlow Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.
Detailed description
Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Wingman Crossing Catheter | Endovascular CTO crossing |
Timeline
- Start date
- 2018-02-13
- Primary completion
- 2019-08-08
- Completion
- 2019-08-08
- First posted
- 2018-01-18
- Last updated
- 2021-01-07
- Results posted
- 2021-01-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03403426. Inclusion in this directory is not an endorsement.