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

Terumo

Status: Unknown

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02188355

T123E2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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