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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2016 |
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Main ID: |
NCT02979236 |
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Date of registration:
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24/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI
iPOSITION |
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Scientific title:
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Prospective, Observational, Italian Multi-center Registry of Self-aPposing cOronary Stent in Patients Presenting With ST-segment Elevation Myocardial InfarcTION: the iPOSITION Registry |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02979236 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Livio Giuliani, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UOSD Emodinamica Diagnostica e Interventistica |
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Name:
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Livio Giuliani, MD PhD |
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Address:
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Telephone:
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347360091 |
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Email:
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lvgiuliani@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ST Segment Elevation Myocardial Infarction
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Intervention(s)
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Device: STENTYS Xposition S
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Primary Outcome(s)
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Target Lesion Failure (TLF)
[Time Frame: 12 months post procedure]
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Secondary Outcome(s)
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Stent thrombosis rate at 30-day and 12-months after the procedure
[Time Frame: 30 days post procedure and 12 months post procedure]
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Death from any cause
[Time Frame: 12 months post procedure]
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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]
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Target lesion failure at 30-day post-procedure
[Time Frame: 30 day post procedure]
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Secondary ID(s)
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CH2016-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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