Trials / Completed
CompletedNCT04162418
A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB
A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- ReFlow Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a commercially available limus-base drug coated balloon.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Temporary Spur Stent System | Treatment of qualifying infrapopliteal lesions with Temporary Spur Stent System and a commercially available, limus-base drug-coated balloon |
Timeline
- Start date
- 2020-02-14
- Primary completion
- 2022-06-30
- Completion
- 2023-09-30
- First posted
- 2019-11-14
- Last updated
- 2023-11-18
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04162418. Inclusion in this directory is not an endorsement.