Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry (e-Ultimaster)
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|ClinicalTrials.gov Identifier: NCT02188355|
Recruitment Status : Recruiting
First Posted : July 11, 2014
Last Update Posted : May 20, 2019
|Condition or disease|
|Coronary Artery Disease|
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]|
|Estimated Enrollment :||37000 participants|
|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|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
- 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.
- 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
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
|Contact: Sabrina Wijnen, MS||+32 16 38 15 17||Sabrina.Wijnen@terumo-europe.com|
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|Study Director:||Vladimir Borovicanin, MD||Terumo Europe|