NCT05292118Completed
Navitian PMCF Study ( rEPIC04C )
Navitian Post-Market Clinical Follow-up Study
Source: ClinicalTrials.gov · Last updated 5 Mar 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 Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 14 Mar 2022
- Start date
- 26 Sept 2022
- Primary completion date
- 11 Jul 2024
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT05292118
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 26 Sept 2022 to the primary completion date, 11 Jul 2024
- 8 sites in 2 countries
- 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
- Patient treated with Navitian 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 (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitario Lucus Agusti Coordinator of this site? Confirm its status | Lugo | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Centro Hospitalar Vila Nova de Gaia Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.