Clinical trial NCT03484234: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Stenosis
Keywords: Drug eluting stent
everolimus eluting stent
sirolimus eluting stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2018-03-30
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. The patient must be at least 19 years of age.
2. 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.
3. Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
4. 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:

1. Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus
2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
3. Acute ST-segment-elevation MI or cardiogenic shock
4. Terminal illness with life expectancy \<1 year
5. In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
6. Patients with EF\<30%.
7. Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
8. Patients with left main stem stenosis (\>50% by visual estimate)

Primary outcomes:
measure: In-segment late luminal loss
timeFrame: 13-month
Secondary outcomes:
measure: All death
timeFrame: 1 year
measure: Cardiac death
timeFrame: 1 year
measure: Myocardial infarction (MI)
timeFrame: 1 year
measure: Composite of death or MI
timeFrame: 1 year
measure: Composite of cardiac death or MI
timeFrame: 1 year
measure: Target vessel revascularization (ischemia-driven and clinically-driven)
timeFrame: 1 year
measure: Target lesion revascularization (ischemia-driven and clinically-driven)
timeFrame: 1 year
measure: Target-vessel failure
timeFrame: 1 year
measure: Stent thrombosis
timeFrame: 1 year
measure: In-stent late loss
timeFrame: 13-month
measure: In-stent and in-segment restenosis
timeFrame: 13-month
measure: Angiographic pattern of restenosis
timeFrame: 13-month
measure: Volume of intimal hyperplasia
timeFrame: 13-month
measure: Incidence of late stent malapposition
timeFrame: 13-month
measure: Procedural success
timeFrame: 5 days
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: