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Comparison of the the Efficacy and Safety of durable polymer Novolimus-eluting Elixir DESyne X2™ Stent with Bioresorbable Polymer Sirolimus-Eluting Orsiro™ Stent in a Real World” patient populatio

Not Applicable
Recruiting
Conditions
Diseases of the circulatory system
Registration Number
KCT0005690
Lead Sponsor
Koera University Guro Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1176
Inclusion Criteria

1) Patient over 20 years old
2) Those who have objective ischemia symptoms such as Stable MI, Unstable MI, Acute or Recent MI or have objective evidence suggesting ischemia by electrocardiogram or functional tests (However, if coronary artery stenosis is more than 70%, no mention of objective ischemia is required)
3) RVD 2.5-4.0mm, Lesion that could be treated with stents.
4) One or more epicardial coronary artery stenosis (above 50%)
5) Patient who agree to sign on ICF.

Exclusion Criteria

1) Patient with cardiogenic shock or SBP less than 80 mmHg.
2) Persons with known hypersensitivity or contraindications to the following drugs and substances: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Biolimus A9, Novolimus, Stainless steal, Cobalt chromium, Contrast agent (However, even subjects with hypersensitivity to contrast agents could be registered if they could be controlled by steroids and pheniramine, but those with known anaphylaxis are excluded.)
3) Lactating and pregnant women. Women who wish to participate other clinical trials.
4) Patient who life expectancy is less than 1 year
5) Patients who disagree to participate in this clinical trial.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cardiogenic death, Q wave MI, or incidence of target lesion failure related to the occurrence of clinically indicated target lesion revascularization at 12 months after PCI.
Secondary Outcome Measures
NameTimeMethod
1) All death 2) Cardiogenic death 3) MI: Q-MI, Non-Q-MI 4) clinical driven TLR 5) clinical driven TVR 6) Any revascularization 7) Stent thrombosis(ARC standard)
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