Navitian PMCF Study ( rEPIC04C )
rEPIC04C
Navitian Post-Market Clinical Follow-up Study
1 other identifier
observational
102
2 countries
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
September 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2024
CompletedMarch 5, 2025
August 1, 2024
1.8 years
March 14, 2022
March 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Endpoint. Freedom fromTarget Lesion Failure
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
7 days
Secondary Outcomes (8)
Efficacy Endpoint. Freedom from Target Lesion Failure
7 days
Freedom from Device rupture
During percutaneous coronary intervention (PCI)
Freedom from Kinking
During PCI
Freedom from Complicated withdrawal
During PCI
Freedom from Coronary perforation
During PCI
- +3 more secondary outcomes
Study Arms (1)
Coronary Artery Disease (CAD)
Interventions
Patients in whom treatment with (Navitian) has been attempted
Eligibility Criteria
Patients treated with Navitian according to routine hospital practice and following instructions for use
You may qualify if:
- Patient treated with Navitian according to routine hospital practice and following instructions for use
- Informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
Study Sites (8)
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, 4434-502, Portugal
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de Leon
León, 24071, Spain
Hospital Universitario Lucus Agusti
Lugo, 27003, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Related Publications (2)
Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.
PMID: 74678BACKGROUNDObata JE, Nakamura T, Kitta Y, Saito Y, Sano K, Fujioka D, Kawabata K, Kugiyama K. Usefulness of a collateral channel dilator for antegrade treatment of chronic total occlusion of a coronary artery. J Interv Cardiol. 2012 Dec;25(6):533-9. doi: 10.1111/j.1540-8183.2012.00758.x. Epub 2012 Jul 23.
PMID: 22823494BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 23, 2022
Study Start
September 26, 2022
Primary Completion
July 11, 2024
Study Completion
July 11, 2024
Last Updated
March 5, 2025
Record last verified: 2024-08