Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study
- Conditions
- Acute ST Segment Elevation Myocardial Infarction
- Interventions
- Device: PCI in patients with ST-elevation myocardial infarction
- Registration Number
- NCT02828683
- Lead Sponsor
- Terumo Europe N.V.
- Brief 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultimaster, Drug Eluting Stent PCI in patients with ST-elevation myocardial infarction Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster Kaname, Bare metal stent PCI in patients with ST-elevation myocardial infarction Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
- Primary Outcome Measures
Name Time Method Target Vessel Failure (TVF) 12 months Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
- Secondary Outcome Measures
Name Time Method Target lesion failure 1 month, 6 months, 12 months, 2 and 3 years 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
Bleeding 1 month, 6 months, 12 months, 2 and 3 years Access or non access site bleeding
Target lesion revascularization 1 month, 6 months, 12 months, 2 and 3 years revascularization of treated lesion
Target vessel failure 1 month, 6 months, 2 and 3 years Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
Stent thrombosis 1 month, 6 months, 12 months, 2 and 3 years Thrombosis in study stents
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization 1 month, 6 months, 12 months, 2 and 3 years Composite of any death, any myocardial infarction, any coronary revascularization
Safety - revascularization, stroke, definite stent thrombosis or major bleeding 1 month revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
In-Stent late loss 6-mnths angiographic assessment of late loss at 6 months
Trial Locations
- Locations (13)
Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria Careggi
🇮🇹Florence, Italy
Cardiologico Monzino
🇮🇹Milan, Italy
San Raffaele Hospital
🇮🇹Milan, Italy
PHE University Cardiology clinic
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Clinical center Nis (CCNIs)
🇷🇸Nis, Serbia
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario Virgen Arrixaca-Murcia
🇪🇸El Palmar, Spain
Hospital Universitario Central Asturias-Oviedo
🇪🇸Oviedo, Spain
Instituto Dante Pazzanese
🇧🇷São Paulo, Brazil
Clinical Hospital Center Zemun (CHC Zemun)
🇷🇸Belgrade, Serbia
Complejo Hospitalario Universitario Santiago de Compostela
🇪🇸Santiago de Compostela, Spain