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)
Verified date | March 2024 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 204 |
Est. completion date | February 13, 2025 |
Est. primary completion date | February 13, 2025 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yongin Severance Hospital | Yongin | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Yonsei University | Terumo Corporation |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |