Status:
TERMINATED
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Coronary Stenosis
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent)....
Eligibility Criteria
Inclusion
- The patient must be at least 19 years of age.
- Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
- Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion
- Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
- Acute ST-segment-elevation MI or cardiogenic shock
- Terminal illness with life expectancy \<1 year
- In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
- Patients with EF\<30%.
- Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
- Patients with left main stem stenosis (\>50% by visual estimate)
Key Trial Info
Start Date :
July 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03484234
Start Date
July 27 2018
End Date
September 6 2019
Last Update
September 10 2019
Active Locations (2)
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1
Gangwon National Univ. Hospital
Chuncheon, South Korea
2
Asan Medical Center
Seoul, South Korea