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

NCT02979236 | Unknown

• 1 other identifier: CH2016-01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

ST Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (1)

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).

Device: STENTYS Xposition S

Interventions

STENTYS Xposition S DEVICE

STEMI treated with STENTYS Xposition S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UOSD Emodinamica Diagnostica e Interventistica: lead

Study Sites (8)

Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo.

Alessandria, Alessandria, 15121, Italy

NOT YET RECRUITING

UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni"

Ascoli Piceno, Ascoli Piceno, 63100, Italy

NOT YET RECRUITING

UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata

Chieti, Chieti, 66100, Italy

RECRUITING

UOC Terapia cardiologica intensiva ed interventistica Azienda Ospedaliera Universitaria G. Martino

Messina, Messina, 98121, Italy

RECRUITING

UOC Cardiologia Emodinamica Ospedale San Salvatore - Centrale

Pesaro, Pesaro, Italy

NOT YET RECRUITING

UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito

Pescara, Pescara, 65121, Italy

NOT YET RECRUITING

UOC Emodinamica Ospedale Umberto I

Syracuse, Siracusa, 96100, Italy

RECRUITING

S.S. Emodinamica Ospedale San Giovanni Bosco

Torino, Torino, 10154, Italy

NOT YET RECRUITING

Related Publications (11)

• 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.

  PMID: 19360868 BACKGROUND

• 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.

  PMID: 21768536 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.

  PMID: 24642998 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.

  PMID: 22285579 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.

  PMID: 24768883 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.

  PMID: 21764660 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.

  PMID: 23257368 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.

  PMID: 25692610 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.

  PMID: 26865444 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.

  PMID: 25440792 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.

  PMID: 20947930 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Livio Giuliani, MD PhD

  UOSD Emodinamica Diagnostica e Interventistica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livio Giuliani, MD PhD

CONTACT

347360091; lvgiuliani@gmail.com

Serena Rossi, MD

CONTACT

3286721396; rossisere.rs@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 1, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

IT (8)