NCT02188355

Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 37,000 (estimated)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2014-06-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2014-07-11
• Last updated: 2019-10-08

Locations

462 sites across 50 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