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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UOSD Emodinamica Diagnostica e Interventistica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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