Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188355
Recruitment Status : Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : October 8, 2019
Sponsor:
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.
Change History Complete list of historical versions of study NCT02188355 on ClinicalTrials.gov Archive Site
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 * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
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
Responsible Party Terumo Europe N.V.
Study Sponsor Terumo Europe N.V.
Collaborators Not Provided
Investigators
Study Director: Vladimir Borovicanin, MD Terumo Europe
PRS Account Terumo Europe N.V.
Verification Date October 2019