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The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition Sâ„¢ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI treated with STENTYS Xposition S | Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STENTYS Xposition S | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | target lesion failure will be assessed as the composite of cardiac death; recurrent Target Vessel-Related Myocardial Infarction (MI) and clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods (CABG). | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay | during the hospitalization, an average of 6 days | |
| Target lesion failure at 30-day post-procedure | 30 day post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years of age and older presenting with symptoms consistent with a ST-Elevation Myocardial Infarction (STEMI) lasting ≤12 hrs in duration, with ≥2 mm of ST-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (Xposition S planned per operator's assessment).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Livio Giuliani, MD PhD | Contact | 347360091 | lvgiuliani@gmail.com | |
| Serena Rossi, MD | Contact | 3286721396 | rossisere.rs@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Livio Giuliani, MD PhD | UOSD Emodinamica Diagnostica e Interventistica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo. | Not yet recruiting | Alessandria | Alessandria | 15121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19360868 | Background | Kim YS, Koo BK, Seo JB, Park KW, Suh JW, Lee HY, Park JS, Kang HJ, Cho YS, Chung WY, Chae IH, Choi DJ, Kim HS, Oh BH, Park YB. The incidence and predictors of postprocedural incomplete stent apposition after angiographically successful drug-eluting stent implantation. Catheter Cardiovasc Interv. 2009 Jul 1;74(1):58-63. doi: 10.1002/ccd.21961. | |
| 21768536 |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Death from any cause | 12 months post procedure |
| Stent thrombosis rate at 30-day and 12-months after the procedure | 30 days post procedure and 12 months post procedure |
|
| UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni" | Not yet recruiting | Ascoli Piceno | Ascoli Piceno | 63100 | Italy |
|
| UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata | Recruiting | Chieti | Chieti | 66100 | Italy |
|
| UOC Terapia cardiologica intensiva ed interventistica Azienda Ospedaliera Universitaria G. Martino | Recruiting | Messina | Messina | 98121 | Italy |
|
| UOC Cardiologia Emodinamica Ospedale San Salvatore - Centrale | Not yet recruiting | Pesaro | Pesaro | Italy |
|
| UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito | Not yet recruiting | Pescara | Pescara | 65121 | Italy |
|
| UOC Emodinamica Ospedale Umberto I | Recruiting | Syracuse | Siracusa | 96100 | Italy |
|
| S.S. Emodinamica Ospedale San Giovanni Bosco | Not yet recruiting | Torino | Torino | 10154 | Italy |
|
| Gutierrez-Chico JL, Regar E, Nuesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18. |
| 24642998 | Background | Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18. |
| 22285579 | Background | Cook S, Eshtehardi P, Kalesan B, Raber L, Wenaweser P, Togni M, Moschovitis A, Vogel R, Seiler C, Eberli FR, Luscher T, Meier B, Juni P, Windecker S. Impact of incomplete stent apposition on long-term clinical outcome after drug-eluting stent implantation. Eur Heart J. 2012 Jun;33(11):1334-43. doi: 10.1093/eurheartj/ehr484. Epub 2012 Jan 26. |
| 24768883 | Background | Nakano M, Yahagi K, Otsuka F, Sakakura K, Finn AV, Kutys R, Ladich E, Fowler DR, Joner M, Virmani R. Causes of early stent thrombosis in patients presenting with acute coronary syndrome: an ex vivo human autopsy study. J Am Coll Cardiol. 2014 Jun 17;63(23):2510-2520. doi: 10.1016/j.jacc.2014.02.607. Epub 2014 Apr 23. |
| 21764660 | Background | Amoroso G, van Geuns RJ, Spaulding C, Manzo-Silberman S, Hauptmann KE, Spaargaren R, Garcia-Garcia HM, Serruys PW, Verheye S. Assessment of the safety and performance of the STENTYS self-expanding coronary stent in acute myocardial infarction: results from the APPOSITION I study. EuroIntervention. 2011 Aug;7(4):428-36. doi: 10.4244/EIJV7I4A71. |
| 23257368 | Background | van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016. |
| 25692610 | Background | Koch KT, Grundeken MJ, Vos NS, IJsselmuiden AJ, van Geuns RJ, Wessely R, Dengler T, La Manna A, Silvain J, Montalescot G, Spaargaren R, Tijssen JG, Amoroso G. One-year clinical outcomes of the STENTYS Self-Apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction: results from the APPOSITION III registry. EuroIntervention. 2015 Jul;11(3):264-71. doi: 10.4244/EIJY15M02_08. |
| 26865444 | Background | van Geuns RJ, Yetgin T, La Manna A, Tamburino C, Souteyrand G, Motreff P, Koch KT, Vrolix M, IJsselmuiden A, Amoroso G, Berland J, Montalescot G, Teiger E, Christiansen EH, Spaargaren R, Wijns W. STENTYS Self-Apposing sirolimus-eluting stent in ST-segment elevation myocardial infarction: results from the randomised APPOSITION IV trial. EuroIntervention. 2016 Feb;11(11):e1267-74. doi: 10.4244/EIJV11I11A248. |
| 25440792 | Background | Grundeken MJ, Lu H, Mehran R, Cutlip DE, Leon MB, Yeung A, Koch KT, Montalescot G, van Geuns RJ, Spaargaren R, Buchbinder M. APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design. Am Heart J. 2014 Nov;168(5):652-60. doi: 10.1016/j.ahj.2014.07.011. Epub 2014 Jul 24. |
| 20947930 | Background | Sianos G, Papafaklis MI, Serruys PW. Angiographic thrombus burden classification in patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention. J Invasive Cardiol. 2010 Oct;22(10 Suppl B):6B-14B. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |