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

UOSD Emodinamica Diagnostica e Interventistica

Status: Unknown

Conditions: ST Segment Elevation Myocardial Infarction

Treatments: Device: STENTYS Xposition S

Study type: Observational

Funder types: Other

Identifiers

NCT02979236

CH2016-01

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 1 patient group

STEMI treated with STENTYS Xposition S

Description:

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).

Treatment:

Device: STENTYS Xposition S