Trials / Unknown
UnknownNCT03842813
Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients
Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,030 (actual)
- Sponsor
- Alvimedica Medical Technologies France · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients. As routine care, each patient will be followed until 12 months after stent implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DES-CRE8 | Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption. |
Timeline
- Start date
- 2019-04-09
- Primary completion
- 2022-02-01
- Completion
- 2022-07-01
- First posted
- 2019-02-15
- Last updated
- 2021-05-10
Locations
22 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03842813. Inclusion in this directory is not an endorsement.