NCT03484234
Terminated
Not Applicable
A Multi-center, Randomized, Study to Compare the Effectiveness of Sirolimus-eluting Stent (Ultimaster Stent) or Everolimus-eluting Stent (XIience Alpine Stent) for Long Coronary Lesions.
Seung-Jung Park2 sites in 1 country36 target enrollmentJuly 27, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Seung-Jung Park
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- In-segment late luminal loss
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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). The study uses a randomized, multicenter, controlled design approach.
Investigators
Seung-Jung Park
Professor, Division of Cardiology
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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)
Outcomes
Primary Outcomes
In-segment late luminal loss
Time Frame: 13-month
Secondary Outcomes
- Target vessel revascularization (ischemia-driven and clinically-driven)(1 year)
- Target-vessel failure(1 year)
- All death(1 year)
- Composite of death or MI(1 year)
- In-stent late loss(13-month)
- Stent thrombosis(1 year)
- Volume of intimal hyperplasia(13-month)
- Myocardial infarction (MI)(1 year)
- In-stent and in-segment restenosis(13-month)
- Angiographic pattern of restenosis(13-month)
- Cardiac death(1 year)
- Composite of cardiac death or MI(1 year)
- Target lesion revascularization (ischemia-driven and clinically-driven)(1 year)
- Incidence of late stent malapposition(13-month)
- Procedural success(5 days)
Study Sites (2)
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