Coronary Artery Disease, Coronary Stenosis
Conditions
Keywords
Drug eluting stent, everolimus eluting stent, sirolimus eluting stent
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.
Interventions
DEVICEUltimaster stent
Percutaneous coronary intervention with Ultimaster stent for long lesion
DEVICEXience alpine stent
Percutaneous coronary intervention with Xience alpine stent for long lesion
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late luminal loss | 13-month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | 1 year | — |
| Myocardial infarction (MI) | 1 year | — |
| Composite of death or MI | 1 year | — |
| Composite of cardiac death or MI | 1 year | — |
| Target vessel revascularization (ischemia-driven and clinically-driven) | 1 year | — |
| Target lesion revascularization (ischemia-driven and clinically-driven) | 1 year | — |
| Target-vessel failure | 1 year | death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization |
| All death | 1 year | — |
| In-stent late loss | 13-month | In-stent late loss at 13-month angiographic follow-up |
| In-stent and in-segment restenosis | 13-month | In-stent and in-segment restenosis at 13-month angiographic follow-up |
| Angiographic pattern of restenosis | 13-month | Angiographic pattern of restenosis at 13 -month angiographic follow-up |
| Volume of intimal hyperplasia | 13-month | Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study) |
| Incidence of late stent malapposition | 13-month | Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study) |
| Procedural success | 5 days | Procedural success defined as achievement of a final diameter stenosis of \<30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay. |
| Stent thrombosis | 1 year | — |
Countries
South Korea
Outcome results
None listed