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

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

— MASTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828683
• Other study ID #: T120E4
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute ST Segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
• PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese	São Paulo
Italy	Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto	Catania
Italy	Azienda Ospedaliero Universitaria Careggi	Florence
Italy	Cardiologico Monzino	Milan
Italy	San Raffaele Hospital	Milan
Macedonia, The Former Yugoslav Republic of	PHE University Cardiology clinic	Skopje
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Hospital Center Zemun (CHC Zemun)	Belgrade
Serbia	Clinical center Nis (CCNIs)	Nis
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Universitario Virgen Arrixaca-Murcia	El Palmar
Spain	Hospital Universitario Central Asturias-Oviedo	Oviedo
Spain	Complejo Hospitalario Universitario Santiago de Compostela	Santiago de Compostela

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Countries where clinical trial is conducted

Brazil,  Italy,  Macedonia, The Former Yugoslav Republic of,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure (TVF)	Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization	12 months
Secondary	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	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Target vessel failure	Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization	1 month, 6 months, 2 and 3 years
Secondary	Stent thrombosis	Thrombosis in study stents	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization	Composite of any death, any myocardial infarction, any coronary revascularization	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Target lesion revascularization	revascularization of treated lesion	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Bleeding	Access or non access site bleeding	1 month, 6 months, 12 months, 2 and 3 years
Secondary	Safety - revascularization, stroke, definite stent thrombosis or major bleeding	revascularization, stroke, definite stent thrombosis or major bleeding at 1 month	1 month
Secondary	In-Stent late loss	angiographic assessment of late loss at 6 months	6-mnths