NCT05292014Completed
ANGIOLITE PMCF Study ( rEPIC04F )
ANGIOLITE Post-Market Clinical Follow-up Study
Source: ClinicalTrials.gov · Last updated 15 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 81 (actual)
- First submitted
- 14 Mar 2022
- Start date
- 26 Sept 2022
- Primary completion date
- 3 Jul 2024
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT05292014
What you commit to
- Study type: Observational
- Participants enrolled: 81
- From 26 Sept 2022 to the primary completion date, 3 Jul 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not meet inclusion criteria
Who the study is looking for
- Patients treated with ANGIOLITE according to routine hospital practice and following instructions for use
- Informed consent signed
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| H. Puerta del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Santiago de Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.