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
- 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
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.
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
Name Time Method 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
Name Time Method 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)