Coronary Artery Disease
Conditions
Keywords
Ultimaster, registry, DES, DAPT
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.
Interventions
None listed
Sponsors
Terumo Europe N.V.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TLF | 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
| Measure | Time frame | Description |
|---|---|---|
| success endpoints | 3 months and 1 year | Procedural success and Device success |
| safety endpoints | 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 | 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 |
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
Outcome results
None listed