Trials / Completed
CompletedNCT04010123
Post-Market Clinical Follow Up of Rotarex®S Catheter
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (actual)
- Sponsor
- Straub Medical AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post-Market Clinical Follow Up of the Rotarex®S Catheter
Detailed description
A prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the Rotarex®S Catheter to evaluate the safety, technical performance and medical efficacy of the Rotarex®S Catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with Rotarex®S Catheter intended use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Atherectomy/Thrombectomy | Percutaneous transluminal removal of thrombotic, thromboembolic and atherothrombotic material from fresh, subacute and chronic occlusions of blood vessels in native blood vessels or vessels fitted with stents, stent grafts or native or artificial bypasses. |
Timeline
- Start date
- 2019-07-17
- Primary completion
- 2022-10-26
- Completion
- 2022-10-26
- First posted
- 2019-07-08
- Last updated
- 2023-02-09
Locations
13 sites across 5 countries: Czechia, Estonia, France, Germany, Italy
Source: ClinicalTrials.gov record NCT04010123. Inclusion in this directory is not an endorsement.