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

NCT03484234 — Not applicable, Terminated, 36 participants, Seung-Jung Park

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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.

RegistryNCT03484234, acronym LONG-DES VII
StatusTerminated - At sponsor's discretion : The purpose of study is no longer maintained
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment36 (Actual)
SponsorSeung-Jung Park (Other); collaborators: CardioVascular Research Foundation, Korea
ConditionsCoronary Artery Disease, Coronary Stenosis
InterventionsUltimaster stent, Xience alpine stent (Device)
Datesstart 2018-07-27, primary completion 2019-09-06, completion 2019-09-06, first posted 2018-03-30, last updated 2019-09-10
Locations2 sites in South Korea

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Ultimaster stentExperimentalDevice: Ultimaster stent
Xience alpine stentActive comparatorDevice: Xience alpine stent
  • Ultimaster stent (Device): Percutaneous coronary intervention with Ultimaster stent for long lesion
  • Xience alpine stent (Device): Percutaneous coronary intervention with Xience alpine stent for long lesion

+Outcome measures

Primary outcomes

  • In-segment late luminal loss [13-month]

Secondary outcomes

  • 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 [1 year]: death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
  • Stent thrombosis [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.

+Eligibility

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)

+Locations (2)

FacilityCityCountryStatus
Gangwon National Univ. HospitalChuncheonSouth Korea
Asan Medical CenterSeoulSouth Korea

My Notes