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Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)

S

Seung-Jung Park

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Cypher
Device: Xience V

Study type

Interventional

Funder types

Other

Identifiers

NCT01078038
2008-0250

Details and patient eligibility

About

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.

Full 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 III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.

Enrollment

451 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

451 participants in 2 patient groups

Cypher
Active Comparator group
Description:
Sirolimus-eluting stent
Treatment:
Device: Cypher
Xience V
Active Comparator group
Description:
Everolimus-eluting stent
Treatment:
Device: Xience V

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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