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

• Conditions: ST Segment Elevation Myocardial Infarction
• Interventions: Device: STENTYS Xposition S

• Registration Number: NCT02979236
• Lead Sponsor: UOSD Emodinamica Diagnostica e Interventistica

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-11
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Study First Posted: 2016-12-01
• Last Update Posted: 2016-12-01
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI treated with STENTYS Xposition S	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).

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months post procedure	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).

Secondary Outcome Measures

Name	Time	Method
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
Death from any cause	12 months post procedure
Target lesion failure at 30-day post-procedure	30 day post procedure
Stent thrombosis rate at 30-day and 12-months after the procedure	30 days post procedure and 12 months post procedure

Trial Locations

Locations (8)

Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo.; 🇮🇹 Alessandria, 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 Emodinamica Ospedale Umberto I; 🇮🇹 Siracusa, Italy

S.S. Emodinamica Ospedale San Giovanni Bosco; 🇮🇹 Torino, Italy

UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni"; 🇮🇹 Ascoli Piceno, Italy

UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito; 🇮🇹 Pescara, Italy