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History of Changes for Study: NCT02188355
Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry (e-Ultimaster)
Latest version (submitted October 6, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 9, 2014 None (earliest Version on record)
2 September 8, 2015 Recruitment Status, Study Status and Contacts/Locations
3 September 10, 2015 Contacts/Locations and Study Status
4 December 10, 2015 Contacts/Locations and Study Status
5 January 20, 2016 Contacts/Locations and Study Status
6 February 11, 2016 Contacts/Locations and Study Status
7 March 15, 2016 Study Status and Contacts/Locations
8 April 22, 2016 Contacts/Locations and Study Status
9 May 31, 2016 Contacts/Locations, Study Status and Outcome Measures
10 June 15, 2016 Study Status and Contacts/Locations
11 July 3, 2016 Contacts/Locations and Study Status
12 July 13, 2016 Contacts/Locations and Study Status
13 October 17, 2016 Contacts/Locations and Study Status
14 January 20, 2017 Contacts/Locations, Study Design and Study Status
15 February 17, 2017 Contacts/Locations and Study Status
16 August 2, 2017 Contacts/Locations, Study Design and Study Status
17 May 17, 2019 Contacts/Locations and Study Status
18 October 6, 2019 Recruitment Status, Contacts/Locations and Study Status
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Study NCT02188355
Submitted Date:  July 9, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: T123E2
Brief Title: Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry (e-Ultimaster)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Not yet recruiting
Study Start: September 2014
Primary Completion: September 2018 [Anticipated]
Study Completion: September 2019 [Anticipated]
First Submitted: July 9, 2014
First Submitted that
Met QC Criteria:
July 9, 2014
First Posted: July 11, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 9, 2014
Last Update Posted: July 11, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Terumo Europe N.V.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Coronary Artery Disease
Keywords: Ultimaster
registry
DES
DAPT
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 17000 [Anticipated]
Number of Groups/Cohorts 0
Target Follow-Up Duration: 1 Year
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
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
Open or close this module Eligibility
Study Population: patient 18 years or older eligible for percutaneous coronary intervention using DES
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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