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Clinical Trials/NCT01186120
NCT01186120CompletedPhase 4

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents

Seung-Jung Park11 sites in 1 country500 target enrollmentStarted: August 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
500
Locations
11
Primary Endpoint
In-segment late luminal loss
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.

Detailed Description

Following angiography, patients with significant diameter stenosis >50% and lesion length(> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

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

Inclusion Criteria

  • •The patient must be at least 18 years of age.
  • •Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
  • •Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
  • •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
  • •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • •In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted) Patients with EF<30%.
  • •Serum creatinine level >=3.0mg/dL or dependence on dialysis.
  • •Patients with left main stem stenosis (>50% by visual estimate).

Outcomes

Primary Outcomes

In-segment late luminal loss

Time Frame: 9 month angiographic follow-up

Secondary Outcomes

  • Composite of cardiac death or MI(1 year)
  • Death (all-cause and cardiac)(9 months)
  • target-lesion revascularization(9 months)
  • target-vessel revascularization(9 months)
  • 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)(12 months)
  • In-stent and in-segment restenosis(9 month angiographic follow-up)
  • In-stent late loss(9 month angiographic follow-up)
  • Angiographic pattern of restenosis(9 month angiographic follow-up)
  • stent thrombosis(ARC criteria)(9 months)
  • Procedural success(at 1 day)
  • Myocardial infarction(9 months)
  • Composite of death or MI(1 year)

Investigators

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

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

CardioVascular Research Foundation, Korea

Study Sites (11)

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