Safety and Efficacy of the Ultimaster Stent

Last updated: November 20, 2025
Sponsor: Yonsei University
Overall Status: Completed

Phase

N/A

Condition

Hypercholesterolemia

Chest Pain

Coronary Artery Disease

Treatment

ultimaster

Clinical Study ID

NCT05677711
9-2021-0152
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-elevationmyocardial infarction, ST-elevation myocardial infarction)

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

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

Exclusion

Exclusion Criteria:

  1. Life expectancy within 1 year

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

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

Study Design

Total Participants: 204
Treatment Group(s): 1
Primary Treatment: ultimaster
Phase:
Study Start date:
July 20, 2021
Estimated Completion Date:
January 03, 2025

Study 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.

Connect with a study center

  • Yongin Severance Hospital

    Yongin, Gyeonggi-do 16995
    Korea, Republic of

    Site Not Available

  • Yongin Severance Hospital

    Yongin, Gyeonggi-do 1841610 16995
    South Korea

    Site Not Available

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