Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry (e-Ultimaster)

• ClinicalTrials.gov Identifier: NCT02188355
• Recruitment Status: Unknown
• First Posted: July 11, 2014
• Last Update Posted: October 8, 2019
• Sponsor: Terumo Europe N.V.
• Information provided by (Responsible Party): Terumo Europe N.V.

Tracking Information

• First Submitted Date: July 9, 2014
• First Posted Date: July 11, 2014
• Last Update Posted Date: October 8, 2019
• Actual Study Start Date: June 2014
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 31, 2016)

TLF [ Time Frame: 1 year ]

Target Lesion Failure defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically drive target lesion revascularization (TLR) at 1 year.

Original Primary Outcome Measures (submitted: July 9, 2014)

TLF [ Time Frame: 1 year ]

Target Lesion Faulure defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically drive target lesion revascularization (TLR) at 1 year.

Current Secondary Outcome Measures (submitted: July 9, 2014)

• success endpoints [ Time Frame: 3 months and 1 year ]
  Procedural success and Device success
• safety endpoints [ Time Frame: 3months and 1 year ]
  cardiac death / mi (peri and post procedural) stent thrombosis (according to ARC definitions) acute/subacute/late primary/secondary Composite endpoint of cardiac death and post procedural MI Composite endpoint of cardiac death , post procedural MI and stent thrombosis rate during the course of DAPT versus the same events after cessaton of DAPT Major vascular and bleeding complications
• efficacy and patient oriented (composite) endpoints [ Time Frame: 3months and 1 year ]
  TLR rate (re-pci/CABG) TLF rate Target Vessel Failure rate (TVF) defined as target vessel revascularization target vessel related q-wave or non q-wave myocardial infarction, or cardiax death that could ot be clearly attributed to a veessl other than the target vessel Patient oriented composite endpoint (POCE) defined as any cause of mortality, mi (q-wave and non qwave) or any TVR

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry
• Official Title: 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
• Brief Summary: The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

Detailed Description

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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: patient 18 years or older eligible for percutaneous coronary intervention using DES
• Condition: Coronary Artery Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Kobo O, Saada M, von Birgelen C, Tonino PAL, Iniguez-Romo A, Frobert O, Halabi M, Oemrawsingh RM, Polad J, IJsselmuiden AJJ, Roffi M, Aminian A, Mamas MA, Roguin A. Impact of Multisite artery disease on Clinical Outcomes After Percutaneous Coronary Intervention: An Analysis from the e-Ultimaster Registry. Eur Heart J Qual Care Clin Outcomes. 2022 Jul 25:qcac043. doi: 10.1093/ehjqcco/qcac043. Online ahead of print.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 2, 2017): 37000
• Original Estimated Enrollment (submitted: July 9, 2014): 17000
• Estimated Study Completion Date: June 2020
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Armenia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Czechia, Egypt, Estonia, France, Georgia, Hungary, Iceland, India, Indonesia, Ireland, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, North Macedonia, Oman, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam
• Removed Location Countries: Czech Republic, Latvia, Macedonia, The Former Yugoslav Republic of

Administrative Information

• NCT Number: NCT02188355
• Other Study ID Numbers: T123E2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Terumo Europe N.V.
• Original Responsible Party: Same as current
• Current Study Sponsor: Terumo Europe N.V.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Vladimir Borovicanin, MD; Terumo Europe

• PRS Account: Terumo Europe N.V.
• Verification Date: October 2019