Overview

This trial is active, not recruiting.

Condition acute st segment elevation myocardial infarction
Treatments pci in patients with st-elevation myocardial infarction
Sponsor Terumo Europe N.V.
Start date July 2013
End date July 2016
Trial size 500 participants
Trial identifier NCT02828683, T120E4

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster
pci in patients with st-elevation myocardial infarction Primary PCI
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
(Active Comparator)
Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
pci in patients with st-elevation myocardial infarction Primary PCI
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction

Primary Outcomes

Measure
Target Vessel Failure (TVF)
time frame: 12 months

Secondary Outcomes

Measure
Target lesion failure
time frame: 1 month, 6 months, 12 months, 2 and 3 years
Target vessel failure
time frame: 1 month, 6 months, 2 and 3 years
Stent thrombosis
time frame: 1 month, 6 months, 12 months, 2 and 3 years
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
time frame: 1 month, 6 months, 12 months, 2 and 3 years
Target lesion revascularization
time frame: 1 month, 6 months, 12 months, 2 and 3 years
Bleeding
time frame: 1 month, 6 months, 12 months, 2 and 3 years
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
time frame: 1 month
In-Stent late loss
time frame: 6-mnths

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age equal or more than 18 years - Chest pain > 20 minutes - Primary PCI <24h from symptoms onset - ST-segment elevation of > 1 mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of > 1 mm in > 2 contiguous anterior leads - Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.5-4.0 mm in diameter that can be covered with one or multiple stents - Signed informed consent Exclusion Criteria: - Female of childbearing potential (age < 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy - Known intolerance to aspirin, clopidogrel, heparin, bivalirudin, cobalt, chromium, nickel, sirolimus or contrast material - Currently participating in another trial before reaching primary endpoint - Mechanical complication of acute myocardial infarction (e.g. cardiogenic shock…) - Acute myocardial infarction secondary to stent thrombosis - Previously stented infarction related artery (IRA) - Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period - Patients with non-cardiac comorbid conditions with life expectancy< 1 year or that may result in protocol non-compliance - History of bleeding diathesis or known coagulopathy - Use of oral anticoagulants

Additional Information

Official title Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Terumo Europe N.V..