Safety and Efficacy of the Ultimaster Stent

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-20

Study Completion Date

2025-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02828683

Acute ST Segment Elevation Myocardial Infarction

COMPLETED NA

Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

NCT05705973

Cardiovascular Disease Coronary Artery Occlusion Ischemic Heart Disease

ACTIVE_NOT_RECRUITING

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)

NCT03484234

Coronary Artery Disease Coronary Stenosis

TERMINATED NA

Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent

NCT02986295

Ischemic Heart Disease

UNKNOWN

Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation

NCT06863155

Coronary Artery Disease Ischemic Heart Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Drug-eluting Stents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultimaster

Ultimaster stent

ultimaster

Intervention Type DEVICE

Subjects who received Ultimaster stent will be included.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultimaster

Subjects who received Ultimaster stent will be included.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No