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Clinical Trials/NCT03484234
NCT03484234TerminatedNot Applicable

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.

Seung-Jung Park2 sites in 1 country36 target enrollmentStarted: July 27, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
36
Locations
2
Primary Endpoint
In-segment late luminal loss
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Ultimaster stent

Experimental

Intervention: Ultimaster stent (Device)

Xience alpine stent

Active Comparator

Intervention: Xience alpine stent (Device)

Outcomes

Primary Outcomes

In-segment late luminal loss

Time Frame: 13-month

Secondary Outcomes

  • Target vessel revascularization (ischemia-driven and clinically-driven)(1 year)
  • Target-vessel failure(1 year)
  • All death(1 year)
  • Composite of death or MI(1 year)
  • In-stent late loss(13-month)
  • Stent thrombosis(1 year)
  • Volume of intimal hyperplasia(13-month)
  • Myocardial infarction (MI)(1 year)
  • In-stent and in-segment restenosis(13-month)
  • Angiographic pattern of restenosis(13-month)
  • Cardiac death(1 year)
  • Composite of cardiac death or MI(1 year)
  • Target lesion revascularization (ischemia-driven and clinically-driven)(1 year)
  • Incidence of late stent malapposition(13-month)
  • Procedural success(5 days)

Investigators

Sponsor
Seung-Jung Park
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

Professor, Division of Cardiology

Asan Medical Center

Study Sites (2)

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