Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry (e-Ultimaster)
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
Sponsor: Terumo Europe N.V.
Listed as NCT02188355, this observational or N/A phase trial focuses on Coronary Artery Disease and remains ongoing. Sponsored by Terumo Europe N.V., it has been updated 14 times since 2014, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.
Study Description(click to expand)All consecutive patients suitable for treatment with DES according to hospital routine practice in centres across the world that agree to participate in the e-ULTIMASTER registry will be treated with Ultimaster DES.
Secondary objectives Evaluation of worldwide utilization of DES, Detection of rare events in representative patient population, identification of predictors of major advers events, assessment of radial access site utilization and its impact on bleeding and vascular complications, assessment of procedural particularities and patients pathology in wide geographic area, assessment of duration and type of DAPT, assesment of the performace of Ultimaster DES is patients lesions subsets, assessment of possible benefits of biodegradable polymer in lager complex patiets/lesions subset and assessment of sirolimus efficacy in different races.
Data will be collected in a e-CRF and online monitoring will be done. Audits will be allowed by sponsor or qualified designees.
All consecutive patients suitable for treatment with DES according to hospital routine practice in centres across the world that agree to participate in the e-ULTIMASTER registry will be treated with Ultimaster DES.
Secondary objectives Evaluation of worldwide utilization of DES, Detection of rare events in representative patient population, identification of predictors of major advers events, assessment of radial access site utilization and its impact on bleeding and vascular complications, assessment of procedural particularities and patients pathology in wide geographic area, assessment of duration and type of DAPT, assesment of the performace of Ultimaster DES is patients lesions subsets, assessment of possible benefits of biodegradable polymer in lager complex patiets/lesions subset and assessment of sirolimus efficacy in different races.
Data will be collected in a e-CRF and online monitoring will be done. Audits will be allowed by sponsor or qualified designees.
Status Flow
Change History
14 versions recorded-
Jan 2026 — Present [monthly]
Unknown
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Sep 2025 — Present [monthly]
Unknown
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Sep 2024 — Sep 2025 [monthly]
Unknown
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Jul 2024 — Sep 2024 [monthly]
Unknown
Status: Unknown Status → Unknown
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Nov 2021 — Jul 2024 [monthly]
Unknown Status
Status: Active Not Recruiting → Unknown Status
▶ Show 9 earlier versions
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Jan 2021 — Nov 2021 [monthly]
Active Not Recruiting
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Nov 2019 — Jan 2021 [monthly]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting
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Jun 2019 — Nov 2019 [monthly]
Recruiting
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Jun 2018 — Jun 2019 [monthly]
Recruiting
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Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Recruiting NA
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Mar 2017 — Aug 2017 [monthly]
Recruiting NA
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Feb 2017 — Mar 2017 [monthly]
Recruiting NA
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Jan 2017 — Feb 2017 [monthly]
Recruiting NA
First recorded
Jun 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Terumo Europe N.V.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
's-Hertogenbosch, Netherlands , A Coruña, Spain , Aalst, Belgium , Abu Dhabi, United Arab Emirates , Aktobe, Kazakhstan , Albacete, Spain , Alexandria, Egypt , Alicante, Spain , Almaty, Kazakhstan , Alor Setar, Kedah, Malaysia and 329 more locations