deltatrials
Unknown OBSERVATIONAL NCT02188355

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.

Updated 14 times since 2017 Last updated: Oct 6, 2019 Started: Jun 30, 2014 Primary completion: Jun 30, 2020 Completion: Jun 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Aug 2017 · 5 months · monthly snapshot~Aug 2017 – ~Apr 2018 · 8 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshot~Jun 2019 – ~Nov 2019 · 5 months · monthly snapshot~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshot~Jan 2021 – ~Nov 2021 · 10 months · monthly snapshot~Nov 2021 – ~Jul 2024 · 32 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

14 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2025 — Present [monthly]

    Unknown

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  5. Nov 2021 — Jul 2024 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

Show 9 earlier versions
  1. Jan 2021 — Nov 2021 [monthly]

    Active Not Recruiting

  2. Nov 2019 — Jan 2021 [monthly]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting

  3. Jun 2019 — Nov 2019 [monthly]

    Recruiting

  4. Jun 2018 — Jun 2019 [monthly]

    Recruiting

  5. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NANone

  6. Aug 2017 — Apr 2018 [monthly]

    Recruiting NA

  7. Mar 2017 — Aug 2017 [monthly]

    Recruiting NA

  8. Feb 2017 — Mar 2017 [monthly]

    Recruiting NA

  9. 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

Sponsor contact:
  • Terumo Europe N.V.
Data source: Terumo Europe N.V.

For direct contact, visit the study record on ClinicalTrials.gov .