Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT05706805
Brief 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.
Study:
NCT05706805
Study Brief:
Protocol Section:
NCT05706805