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Clinical Trial Summary

The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry. Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients. The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.


Clinical Trial Description

- Prospective, observational, noninterventional, multicenter, international clinical registry - Allocation: consecutively treated patients, non-randomized - Masking: None (open label) - Observational model: Longitudinal - Inclusion period: 2 years - Follow-up period: at 1 year - Study duration: 3 years Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients. The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected. List of visits: V0: During hospitalization: consultation baseline, data of the intervention and data at discharge V1: consultation at 30 days Follow-Up V2: consultation at 12 months Follow-Up ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05703646
Study type Observational [Patient Registry]
Source Translumina GmbH
Contact NANCY CHUGH
Phone +91-9996235253
Email drnancychugh@translumina.in
Status Recruiting
Phase
Start date March 30, 2023
Completion date March 30, 2026

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