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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.
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 Navitian 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navitian | Device | Patients in whom treatment with (Navitian) has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Freedom from Device rupture |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Navitian according to routine hospital practice and following instructions for use
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Vila Nova de Gaia | Vila Nova de Gaia | 4434-502 | Portugal | |||
| Hospital Universitari Vall D'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 74678 | Background | 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. | |
| 22823494 | Background | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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Freedom from Device rupture
| During percutaneous coronary intervention (PCI) |
| Freedom from Kinking | Freedom from Kinking | During PCI |
| Freedom from Complicated withdrawal | Freedom from Complicated withdrawal | During PCI |
| Freedom from Coronary perforation | Freedom from Coronary perforation | During PCI |
| Freedom from Coronary dissection >C | Freedom from Coronary dissection >C | During PCI |
| Freedom from No reflow | Freedom from No reflow | During PCI |
| Freedom from Coronary thrombosis | Freedom from Coronary thrombosis | During PCI |
| 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 |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |