Trials / Completed
CompletedNCT05292014
ANGIOLITE PMCF Study ( rEPIC04F )
ANGIOLITE Post-Market Clinical Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 81 (actual)
- Sponsor
- Fundación EPIC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Angiolite sirolimus eluting stent.
Detailed description
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Angiolite Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ANGIOLITE | Patients in whom treatment with ANGIOLITE has been attempted |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2024-07-03
- Completion
- 2024-08-03
- First posted
- 2022-03-23
- Last updated
- 2025-06-15
Locations
6 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05292014. Inclusion in this directory is not an endorsement.