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

November 28, 2016 updated by: Livio Giuliani, UOSD Emodinamica Diagnostica e Interventistica

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy, 15121
        • Not yet recruiting
        • Dipartimento cardiotoracico e vascolare - S.S Emodinamica Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo.
        • Contact:
      • Ascoli Piceno, Italy, 63100
        • Not yet recruiting
        • UOC Cardiologia- UTIC Ospedale Civile "C. e G.Mazzoni"
        • Contact:
      • Chieti, Italy, 66100
        • Recruiting
        • UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata
        • Contact:
        • Contact:
      • Messina, Italy, 98121
        • Recruiting
        • UOC Terapia cardiologica intensiva ed interventistica Azienda Ospedaliera Universitaria G. Martino
        • Contact:
      • Pesaro, Italy
        • Not yet recruiting
        • UOC Cardiologia Emodinamica Ospedale San Salvatore - Centrale
        • Contact:
      • Pescara, Italy, 65121
        • Not yet recruiting
        • UOC UTIC e Cardiologia Interventistica Ospedale S. Spirito
        • Contact:
      • Siracusa, Italy, 96100
      • Torino, Italy, 10154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Lesion Failure (TLF)
Time Frame: 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).
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success without the occurrence of death and repeat ischemia-driven revascularization of the target lesion during the hospital stay
Time Frame: during the hospitalization, an average of 6 days
during the hospitalization, an average of 6 days
Target lesion failure at 30-day post-procedure
Time Frame: 30 day post procedure
30 day post procedure
Death from any cause
Time Frame: 12 months post procedure
12 months post procedure
Stent thrombosis rate at 30-day and 12-months after the procedure
Time Frame: 30 days post procedure and 12 months post procedure
30 days post procedure and 12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UOSD Emodinamica Diagnostica e Interventistica

Investigators

  • Principal Investigator: Livio Giuliani, MD PhD, UOSD Emodinamica Diagnostica e Interventistica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH2016-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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