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.
| Registry | NCT03484234, acronym LONG-DES VII |
|---|---|
| Status | Terminated - At sponsor's discretion : The purpose of study is no longer maintained |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 36 (Actual) |
| Sponsor | Seung-Jung Park (Other); collaborators: CardioVascular Research Foundation, Korea |
| Conditions | Coronary Artery Disease, Coronary Stenosis |
| Interventions | Ultimaster stent, Xience alpine stent (Device) |
| Dates | start 2018-07-27, primary completion 2019-09-06, completion 2019-09-06, first posted 2018-03-30, last updated 2019-09-10 |
| Locations | 2 sites in South Korea |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ultimaster stent | Experimental | Device: Ultimaster stent | |
| Xience alpine stent | Active comparator | Device: Xience alpine stent |
Sex: All, ages: 19 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Gangwon National Univ. Hospital | Chuncheon | South Korea | |
| Asan Medical Center | Seoul | South Korea |