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

NCT02828683 | Completed DMC

• 1 other identifier: T120E4
• Study Type: interventional
• Target: 500
• Locations: 5 countries
• Sites: 13

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.

Conditions

Acute ST Segment Elevation Myocardial Infarction

Keywords

DES; PCI; STEMI; Interventional Cardiology

Outcome Measures

Primary Outcomes (1)

• Target Vessel Failure (TVF)

  Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization

  12 months

Secondary Outcomes (8)

• Target lesion failure

  1 month, 6 months, 12 months, 2 and 3 years

• Target vessel failure

  1 month, 6 months, 2 and 3 years

• Stent thrombosis

  1 month, 6 months, 12 months, 2 and 3 years

• Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization

  1 month, 6 months, 12 months, 2 and 3 years

• Target lesion revascularization

  1 month, 6 months, 12 months, 2 and 3 years

Study Arms (2)

Ultimaster, Drug Eluting Stent

EXPERIMENTAL

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

Kaname, Bare metal stent

ACTIVE COMPARATOR

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

Interventions

PCI in patients with ST-elevation myocardial infarction DEVICE

Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)

Also known as: Primary PCI

Ultimaster, Drug Eluting Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (13)

Instituto Dante Pazzanese

São Paulo, Brazil

Location

Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto

Catania, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

Location

Cardiologico Monzino

Milan, Italy

Location

San Raffaele Hospital

Milan, Italy

Location

PHE University Cardiology clinic

Skopje, 1000, North Macedonia

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical Hospital Center Zemun (CHC Zemun)

Belgrade, Serbia

Location

Clinical center Nis (CCNIs)

Niš, Serbia

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Hospital Universitario Virgen Arrixaca-Murcia

El Palmar, Spain

Location

Hospital Universitario Central Asturias-Oviedo

Oviedo, Spain

Location

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, Spain

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Vladimir Borovicanin, MD

  Terumo Europe

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: July 12, 2016
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: May 1, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

BR (1); ES (4); IT (4); SE (3); NO (1)