Ischemic Heart Disease Clinical Trial
— rEPIC04COfficial title:
Navitian Post-Market Clinical Follow-up Study
| Verified date | July 2023 |
| Source | Fundación EPIC |
| Contact | FUNDACION EPIC |
| Phone | 987225638 |
| iepic[@]fundacionepic.org | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 113 |
| Est. completion date | March 30, 2025 |
| Est. primary completion date | March 2, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient treated with Navitian according to routine hospital practice and following instructions for use - Informed consent signed Exclusion Criteria: - Not meet inclusion criteria |
| Country | Name | City | State |
|---|---|---|---|
| Portugal | Centro Hospitalar Vila Nova de Gaia | Vila Nova De Gaia | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari Vall D'Hebron | Barcelona | |
| Spain | Hospital Universitario Juan Ramon Jimenez | Huelva | |
| Spain | Hospital Universitario de Leon | León | |
| Spain | Hospital Universitario Lucus Agusti | Lugo | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | |
| Spain | Hospital Clinico Universitario de Valladolid | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación EPIC |
Portugal, Spain,
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. — View Citation
Obata 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Efficacy Endpoint. Freedom from Target Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR). | 7 days | |
| Secondary | Freedom from Device rupture | Freedom from Device rupture | During percutaneous coronary intervention (PCI) | |
| Secondary | Freedom from Kinking | Freedom from Kinking | During PCI | |
| Secondary | Freedom from Complicated withdrawal | Freedom from Complicated withdrawal | During PCI | |
| Secondary | Freedom from Coronary perforation | Freedom from Coronary perforation | During PCI | |
| Secondary | Freedom from Coronary dissection >C | Freedom from Coronary dissection >C | During PCI | |
| Secondary | Freedom from No reflow | Freedom from No reflow | During PCI | |
| Secondary | Freedom from Coronary thrombosis | Freedom from Coronary thrombosis | During PCI |
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