Safety and Efficacy of the Ultimaster Stent

Coronary Artery Disease Clinical Trial

Official title:

A Prospective, Observational Study of the Real World Safety and Effectiveness of the Ultimaster Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions in All-comer Patients (MASTER Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05677711
• Other study ID #: 9-2021-0152
• Status: Active, not recruiting
• Start date: July 20, 2021
• Est. completion date: February 13, 2025

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Durable polymer was considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. Ultimaster stent (Ultimaster, Terumo Corporation, Tokyo, Japan) are thin strut, silorimus-eluting, biodegradable copolymer to completely degrade over 3-4 months.

Description:

Drug-eluting stents (DES) significantly improved outcome compared wiht bare-metal stents because of slow-elution of the antiproliferative drug mixed with a polymer coated on the stent surface. However, the polymers used in the first-generation DES were considered to be the cause of a chronic inflammatory response that leadas to impaired endothelialization of the stent strut and subsequently increases the risk of stent thrombosis. One strategy to mitigate this problem is a biodegradable polymer, which dissolves over time and leaves only the metalic struts behind. Ultimaster stent are silorimus-eluting, biodegradable poly DL-lactide-co-caprolactone copolymer (PDLLA+PCL) to completely degrade over 3-4 months and is also made of 80μm thin strut. The aim of the current study is to investigate the efficacy and safety outcomes in patients treated with ultimaster stents in real-world.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 204
• Est. completion date: February 13, 2025
• Est. primary completion date: February 13, 2025
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Age 19 or older

2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction, ST-elevation myocardial infarction)

3. No restrictions on the number of blood vessels, number of lesions, and length of lesions

4. Those who voluntarily gave written consent to participate in this clinical study

Exclusion Criteria:

1. Life expectancy within 1 year

2. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor

3. If other researchers judge that it is inappropriate to participate in this study

Related Conditions & MeSH terms

• Coronary Artery Disease
• Drug-eluting Stents

Intervention

Device:
• ultimaster
Subjects who received Ultimaster stent will be included.

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Terumo Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion failures (TLF) per 1 year	Number of 1-year TLF are defined as combination of cardiac death, target vascular myocardial infarction, and ischemia-induced target lesion revascularization	12 months
Secondary	Major Cardiac Adverse Events (MACE) in 1 Year	Number of 1-year MACE are defined as combination of summation of death, myocardial infarction, stent thrombosis, composite variable of target lesion revascularization	12 months
Secondary	cardiac deaths per year	Number of cardiac death at 1 year	12 months
Secondary	1-year non-cardiac death	Number of 1-year non-cardiac death	12 months
Secondary	1-year target vessel myocardial infarction	Number of 1-year target vascular myocardial infarction	12 months
Secondary	1-year Number of non-target vascular myocardial infarction	Number of 1-year non-target vascular myocardial infarction	12 months
Secondary	ischemia-induced target lesion revascularization in 1 year	Number of 1-year ischemia-induced target lesion revascularization	12 months
Secondary	non-ischemic target lesion revascularization in 1 year	Number of 1-year non-ischemic target lesion revascularization	12 months
Secondary	acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year	Number of acute certain or probable stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year	within 24 hours, within 30 days, and late stent thrombosis at 1 year
Secondary	strokes per year	Number of 1 year ischemic or hemorrhagic stroke	12 months
Secondary	bleeding events per year	Number of 1-year bleeding rate (Bleeding Academic Research Consortium 2-5)	12 months