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International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent 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) and high risk of bleeding |
| ||
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coroflex® ISAR NEO coronary stent system | Device | Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint. Freedom from Target Lesion Failure | Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR) | 7 days |
| Efficacy 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 |
|---|---|---|
| Freedom from Accidental dislodgement of the stent | Freedom from Accidental dislodgement of the stent | During percutaneous coronary intervention (PCI) |
| Freedom from Balloon rupture | Freedom from Balloon rupture |
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Inclusion Criteria:
Coroflex® ISAR NEO is intended to be used for
Exclusion Criteria:
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Patients treated with Coroflex® ISAR NEO coronary stent system according to routine hospital practice and following instructions for use
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| koldobika García San Román, MD, PhD | Contact | 0034696704643 | koldobikags@hotmail.com | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier du Pays d'Aix | Recruiting | Aix-en-Provence | 13100 | France | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31116395 | Background | Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372. | |
| 30165437 |
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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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| During PCI |
| Freedom from Hypotube rupture | Freedom from Hypotube rupture | 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 |
| Centre Hospitalier Ajaccio |
| Recruiting |
| Ajaccio |
| 20090 |
| France |
| CH Polyclinique Bordeaux Nord Aquitaine | Recruiting | Bordeaux | 33300 | France |
| University Hospital Center of Caen | Recruiting | Caen | 14000 | France |
| Hôpital Albert Schweitzer | Recruiting | Colmar | France |
| Hospitalario Universitario (CHU) de Lille | Recruiting | Lille | 59000 | France |
| APHP -Hôpital Lariboisière | Recruiting | Paris | 75010 | France |
| Institut Arnault Tzanck | Recruiting | Saint-Laurent-du-Var | 06700 | France |
| Hospital Universitario A Coruña | Recruiting | A Coruña | 15006 | Spain |
| Hospital Universitario de Badajoz | Recruiting | Badajoz | 06080 | Spain |
| Hospital Universitari Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital Universitario de Cruces | Recruiting | Barakaldo | 48903 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hospital Universitari Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario San Pedro de Alcantara | Recruiting | Cáceres | 10003 | Spain |
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Recruiting | Huelva | 21005 | Spain |
| Hospital Universitario de Leon | Recruiting | León | 24071 | Spain |
| Hospital Universitario Lucus Agusti | Recruiting | Lugo | 27003 | Spain |
| Hospital Regional Universitario de Málaga | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| Background |
| Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. |
| 31504439 | Background | Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. |
| Background | Ruiz-Nodar JM, Ferreiro JL. Tratamiento antitrómbotico tras revascularización percutánea en pacientes con indicación crónica de anticoagulación oral. REC Interv Cardiol. 2019;1(1):41-50. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |