Trials / Completed
CompletedNCT05292105
NC Xperience PMCF Study( rEPIC04B)
NC Xperience Post-Market Clinical Follow-up Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 59 (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 NC Xperience to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with NC Xperience .
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 NC Xperience 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 | NC Xperience | Coronary dilatation balloon catheter (non compliant) |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2023-04-26
- Completion
- 2023-05-05
- First posted
- 2022-03-23
- Last updated
- 2024-01-31
Locations
3 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05292105. Inclusion in this directory is not an endorsement.