Trials / Completed
CompletedNCT05706805
NAVISCORE PMCF Study ( rEPIC04F )
NAVISCORE Post-Market Clinical Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 54 (actual)
- Sponsor
- Fundación EPIC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.
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 Naviscore scoring balloon 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 | Naviscore | Patients in whom treatment with (Naviscore) has been attempted |
Timeline
- Start date
- 2023-01-31
- Primary completion
- 2023-09-27
- Completion
- 2023-09-27
- First posted
- 2023-01-31
- Last updated
- 2024-02-06
Locations
7 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05706805. Inclusion in this directory is not an endorsement.