Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI

ST Segment Elevation Myocardial Infarction Clinical Trial

— iPOSITION  

Official title:

Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02979236
• Other study ID #: CH2016-01
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2016
• Last updated: November 28, 2016
• Start date: June 2016

Study information

• Verified date: November 2016
• Source: UOSD Emodinamica Diagnostica e Interventistica
• Contact: Livio Giuliani, MD PhD
• Phone: 347360091
• Email: lvgiuliani[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of this registry is to collect clinical data on nitinol self-expanding STENTYS Xposition S™ in order to evaluate the efficacy and safety in patients presenting with ST segment elevation myocardial infarction

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Cardiogenic shock

• Multiple lesions requiring stenting in the target vessel.

• Highly calcified lesions or excessive tortuosity at target lesion site.

• Intrastent pathology.

• Subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines.

• Female subjects of childbearing potential known to be pregnant.

• Co-morbidities with life expectancy less than 1 year

• Patient unable to provide written informed consent.

• Known allergies to stent component.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Device:
• STENTYS Xposition S

Locations

Country	Name	City	State
Italy	Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo.	Alessandria
Italy	UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni"	Ascoli Piceno
Italy	UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata	Chieti
Italy	UOC Terapia cardiologica intensiva ed interventistica Azienda Ospedaliera Universitaria G. Martino	Messina
Italy	UOC Cardiologia Emodinamica Ospedale San Salvatore - Centrale	Pesaro
Italy	UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito	Pescara
Italy	UOC Emodinamica Ospedale Umberto I	Siracusa
Italy	S.S. Emodinamica Ospedale San Giovanni Bosco	Torino

Sponsors (1)

Lead Sponsor	Collaborator
UOSD Emodinamica Diagnostica e Interventistica

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Amoroso G, van Geuns RJ, Spaulding C, Manzo-Silberman S, Hauptmann KE, Spaargaren R, García-García 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. — View Citation

Cook S, Eshtehardi P, Kalesan B, Räber L, Wenaweser P, Togni M, Moschovitis A, Vogel R, Seiler C, Eberli FR, Lüscher T, Meier B, Jüni 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. — View Citation

Foin N, Gutiérrez-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. — View Citation

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. — View Citation

Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni 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. — View Citation

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. — View Citation

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. — View Citation

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):2510-20. doi: 10.1016/j.jacc.2014.02.607. — View Citation

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. — View Citation

van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, García-García 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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Target lesion failure at 30-day post-procedure		30 day post procedure	No
Secondary	Death from any cause		12 months post procedure	No
Secondary	Stent thrombosis rate at 30-day and 12-months after the procedure		30 days post procedure and 12 months post procedure	No