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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Acute ST Segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultimaster, Drug Eluting Stent

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

Group Type EXPERIMENTAL

PCI in patients with ST-elevation myocardial infarction

Intervention Type DEVICE

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

Kaname, Bare metal stent

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

Group Type ACTIVE_COMPARATOR

PCI in patients with ST-elevation myocardial infarction

Intervention Type DEVICE

Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction

Interventions

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PCI in patients with ST-elevation myocardial infarction

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

Intervention Type DEVICE

PCI in patients with ST-elevation myocardial infarction

Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction

Intervention Type DEVICE

Other Intervention Names

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Primary PCI Primary PCI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No