Safety and Efficacy of the Ultimaster Stent

Yonsei University

Status: Completed

Conditions: Coronary Artery Disease; Drug-eluting Stents

Treatments: Device: ultimaster

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05677711

9-2021-0152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

204 participants in 1 patient group

Ultimaster

Description:

Ultimaster stent

Treatment:

Device: ultimaster