Clinical trial NCT05677711: Safety and Efficacy of the Ultimaster Stent
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Drug-eluting Stents
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Terumo Corporation
First posted: 2023-01-10
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated with Ultimaster® stents

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: target lesion failures (TLF) per 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Major Cardiac Adverse Events (MACE) in 1 Year
timeFrame: 12 months
measure: cardiac deaths per year
timeFrame: 12 months
measure: 1-year non-cardiac death
timeFrame: 12 months
measure: 1-year target vessel myocardial infarction
timeFrame: 12 months
measure: 1-year Number of non-target vascular myocardial infarction
timeFrame: 12 months
measure: ischemia-induced target lesion revascularization in 1 year
timeFrame: 12 months
measure: non-ischemic target lesion revascularization in 1 year
timeFrame: 12 months
measure: acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year
timeFrame: within 24 hours, within 30 days, and late stent thrombosis at 1 year
measure: strokes per year
timeFrame: 12 months
measure: bleeding events per year
timeFrame: 12 months
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
References: