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

Primary Purpose

Acute ST Segment Elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PCI in patients with ST-elevation myocardial infarction
PCI in patients with ST-elevation myocardial infarction
Sponsored by
Terumo Europe N.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST Segment Elevation Myocardial Infarction focused on measuring DES, PCI, STEMI, Interventional Cardiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Dante Pazzanese
  • Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
  • Azienda Ospedaliero Universitaria Careggi
  • Cardiologico Monzino
  • San Raffaele Hospital
  • PHE University Cardiology clinic
  • Clinical Center of Serbia
  • Clinical Hospital Center Zemun (CHC Zemun)
  • Clinical center Nis (CCNIs)
  • Complejo Hospitalario Universitario A Coruña
  • Hospital Universitario Virgen Arrixaca-Murcia
  • Hospital Universitario Central Asturias-Oviedo
  • Complejo Hospitalario Universitario Santiago de Compostela

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultimaster, Drug Eluting Stent

Kaname, Bare metal stent

Arm Description

Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster

Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname

Outcomes

Primary Outcome Measures

Target Vessel Failure (TVF)
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization

Secondary Outcome Measures

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
Target vessel failure
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
Stent thrombosis
Thrombosis in study stents
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
Composite of any death, any myocardial infarction, any coronary revascularization
Target lesion revascularization
revascularization of treated lesion
Bleeding
Access or non access site bleeding
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
In-Stent late loss
angiographic assessment of late loss at 6 months

Full Information

First Posted
May 16, 2013
Last Updated
July 3, 2018
Sponsor
Terumo Europe N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02828683
Brief Title
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Terumo Europe N.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Segment Elevation Myocardial Infarction
Keywords
DES, PCI, STEMI, Interventional Cardiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultimaster, Drug Eluting Stent
Arm Type
Experimental
Arm Description
Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster
Arm Title
Kaname, Bare metal stent
Arm Type
Active Comparator
Arm Description
Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
Intervention Type
Device
Intervention Name(s)
PCI in patients with ST-elevation myocardial infarction
Other Intervention Name(s)
Primary PCI
Intervention Description
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Intervention Type
Device
Intervention Name(s)
PCI in patients with ST-elevation myocardial infarction
Other Intervention Name(s)
Primary PCI
Intervention Description
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Primary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Description
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Target lesion failure
Description
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
Title
Target vessel failure
Description
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
Time Frame
1 month, 6 months, 2 and 3 years
Title
Stent thrombosis
Description
Thrombosis in study stents
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
Description
Composite of any death, any myocardial infarction, any coronary revascularization
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Target lesion revascularization
Description
revascularization of treated lesion
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Bleeding
Description
Access or non access site bleeding
Time Frame
1 month, 6 months, 12 months, 2 and 3 years
Title
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
Description
revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
Time Frame
1 month
Title
In-Stent late loss
Description
angiographic assessment of late loss at 6 months
Time Frame
6-mnths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Borovicanin, MD
Organizational Affiliation
Terumo Europe
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Dante Pazzanese
City
São Paulo
Country
Brazil
Facility Name
Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Cardiologico Monzino
City
Milan
Country
Italy
Facility Name
San Raffaele Hospital
City
Milan
Country
Italy
Facility Name
PHE University Cardiology clinic
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Clinical Center of Serbia
City
Belgrade
Country
Serbia
Facility Name
Clinical Hospital Center Zemun (CHC Zemun)
City
Belgrade
Country
Serbia
Facility Name
Clinical center Nis (CCNIs)
City
Nis
Country
Serbia
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
Country
Spain
Facility Name
Hospital Universitario Virgen Arrixaca-Murcia
City
El Palmar
Country
Spain
Facility Name
Hospital Universitario Central Asturias-Oviedo
City
Oviedo
Country
Spain
Facility Name
Complejo Hospitalario Universitario Santiago de Compostela
City
Santiago de Compostela
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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