NCT02828683

Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study

Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.

Detailed description

MASTER is prospective, randomized (3:1), single blind, controlled, superiority (efficacy) and non-inferiority (safety and efficacy), multi center, two-arm trial of TCD-10023 (Ultimaster) drug eluting stent (test) and Kaname bare metal stent (comparator). Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 3 years. 500 patients with clinical follow up will be randomized in 3:1 ratio (375 in TCD-10023 arm and 125 in Kaname arm). Among them, 100 patients will be randomized in the same, 3:1 ratio, to angiographic follow up at 6 months in preselected hospitals (75 in TCD-10023 and 25 in Kaname arm)

Conditions

• Acute ST Segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	PCI in patients with ST-elevation myocardial infarction	Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
DEVICE	PCI in patients with ST-elevation myocardial infarction	Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-07-01
• Completion: 2018-05-01
• First posted: 2016-07-12
• Last updated: 2018-07-05

Locations

13 sites across 5 countries: Brazil, Italy, North Macedonia, Serbia, Spain