Clinical trial NCT02979236: Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST Segment Elevation Myocardial Infarction
Lead sponsor: UOSD Emodinamica Diagnostica e Interventistica
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


Eligibility criteria: 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.

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay
timeFrame: during the hospitalization, an average of 6 days
measure: Target lesion failure at 30-day post-procedure
timeFrame: 30 day post procedure
measure: Death from any cause
timeFrame: 12 months post procedure
measure: Stent thrombosis rate at 30-day and 12-months after the procedure
timeFrame: 30 days post procedure and 12 months post procedure
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo.
city: Ascoli Piceno
country: Italy
facility: UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni"
city: Chieti
country: Italy
facility: UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata
city: Messina
country: Italy
facility: UOC Terapia cardiologica intensiva ed interventistica Azienda Ospedaliera Universitaria G. Martino
city: Pesaro
country: Italy
facility: UOC Cardiologia Emodinamica Ospedale San Salvatore - Centrale
city: Pescara
country: Italy
facility: UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito
city: Siracusa
country: Italy
facility: UOC Emodinamica Ospedale Umberto I
city: Torino
country: Italy
facility: S.S. Emodinamica Ospedale San Giovanni Bosco
Study officials:
affiliation: UOSD Emodinamica Diagnostica e Interventistica
name: Livio Giuliani, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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