Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Coronary Artery Disease, Coronary Stenosis

Intervention / Treatment
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* Device: Ultimaster stent
* Device: Xience alpine stent


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultimaster stent<br> | Device: Ultimaster stent<br>* Percutaneous coronary intervention with Ultimaster stent for long lesion<br>|
| Active Comparator: Xience alpine stent<br> | Device: Xience alpine stent<br>* Percutaneous coronary intervention with Xience alpine stent for long lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late luminal loss |  | 13-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death |  | 1 year | 
| 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 | death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization | 1 year | 
| Stent thrombosis |  | 1 year | 
| In-stent late loss | In-stent late loss at 13-month angiographic follow-up | 13-month | 
| In-stent and in-segment restenosis | In-stent and in-segment restenosis at 13-month angiographic follow-up | 13-month | 
| Angiographic pattern of restenosis | Angiographic pattern of restenosis at 13 -month angiographic follow-up | 13-month | 
| Volume of intimal hyperplasia | Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study) | 13-month | 
| Incidence of late stent malapposition | Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study) | 13-month | 
| Procedural success | 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. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stent, everolimus eluting stent, sirolimus eluting stent