An interventional study of PCI in patients with ST-elevation myocardial infarction and PCI in patients with ST-elevation myocardial infarction in Acute ST Segment Elevation Myocardial Infarction, sponsored by Terumo Europe N.V.. Completed at 13 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.
Sponsored by Terumo Europe N.V. · Not applicable, Interventional, and Treatment
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.
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)
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 500 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Terumo Europe N.V. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster
Device: PCI in patients with ST-elevation myocardial infarction
Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
Device: PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Also known as: Primary PCI
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Also known as: Primary PCI
Target Vessel Failure (TVF)
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
Time frame: 12 months
Target lesion failure
Composite of cardiac death, target vessel myocardial infarction, target lesion revascularization 2. Target vessel failure (TVF) Comosite of cardiac death, target vessel myocardial infarction, target lesion revascularization
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Target vessel failure
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
Time frame: 1 month, 6 months, 2 and 3 years
Stent thrombosis
Thrombosis in study stents
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
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
revascularization of treated lesion
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Bleeding
Access or non access site bleeding
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
Time frame: 1 month
In-Stent late loss
angiographic assessment of late loss at 6 months
Time frame: 6-mnths
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Terumo Europe N.V.