Trials / Unknown
UnknownNCT03386370
The Indigo System in Acute Lower Limb Malperfusion
Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Azienda Ospedaliera Universitaria Senese · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | "Indigo" Mechanical Thrombectomy System | Removal of acute clot (\< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra |
Timeline
- Start date
- 2017-09-01
- Primary completion
- 2019-03-01
- Completion
- 2019-05-01
- First posted
- 2017-12-29
- Last updated
- 2019-01-10
Locations
1 site across 1 country: Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03386370. Inclusion in this directory is not an endorsement.