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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 2020 |
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Main ID: |
NCT02188355 |
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Date of registration:
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09/07/2014 |
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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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Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry
e-Ultimaster |
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Scientific title:
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Prospective, Single Arm, Multi-centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster Des System in Unselected Patients Representing Everyday Clinical Practice |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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37000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02188355 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Armenia
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Austria
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Bangladesh
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Belarus
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Belgium
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Brazil
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Bulgaria
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Chile
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Colombia
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Czech Republic
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Czechia
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Egypt
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Estonia
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France
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Georgia
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Hungary
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Iceland
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India
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Indonesia
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Ireland
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Israel
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Japan
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Jordan
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Kazakhstan
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Kuwait
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Latvia
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Lebanon
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Lithuania
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Macedonia, The Former Yugoslav Republic of
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Malaysia
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Mexico
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Morocco
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Netherlands
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North Macedonia
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Oman
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Poland
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Portugal
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Romania
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Saudi Arabia
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Serbia
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Slovakia
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South Africa
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Spain
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Sweden
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Switzerland
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Thailand
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Tunisia
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Ukraine
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United Arab Emirates
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United Kingdom
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Uzbekistan
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Vietnam
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Contacts
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Name:
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Vladimir Borovicanin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Terumo Europe |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years or older
- eligible for percutaneous coronary intervention using DES (and RVD matches available
Ultimaster DES sizes)
- informed about the nature of the study and agreess to its provisionss and has provided
written informed consent as approved by the Institutional Review Board / Ethics
committee of the respective clinical site, wherever such requirement exists.
Exclusion Criteria:
- following instruction for use
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Primary Outcome(s)
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TLF
[Time Frame: 1 year]
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Secondary Outcome(s)
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success endpoints
[Time Frame: 3 months and 1 year]
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efficacy and patient oriented (composite) endpoints
[Time Frame: 3months and 1 year]
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safety endpoints
[Time Frame: 3months and 1 year]
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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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