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

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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.

Study Description
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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.

Condition or disease
Coronary Artery Disease

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 37000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : June 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. success endpoints [ Time Frame: 3 months and 1 year ]
    Procedural success and Device success

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient 18 years or older eligible for percutaneous coronary intervention using DES
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188355


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Sponsors and Collaborators
Terumo Europe N.V.
Investigators
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Study Director: Vladimir Borovicanin, MD Terumo Europe
More Information
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Additional Information:

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Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT02188355     History of Changes
Other Study ID Numbers: T123E2
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Keywords provided by Terumo Europe N.V.:
Ultimaster
registry
DES
DAPT
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases