LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

Launched by SEUNG-JUNG PARK · Dec 9, 2011

Keywords

ClinConnect Summary

Following angiography, patients with significant diameter stenosis \> 50% and lesion length (\> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age more than 20 years
• • Significant native coronary artery stenosis (\> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment
• • Patients with silent ischemia, stable or unstable angina pectoris, and 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, zotarolimus, 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) However, non-target vessel In-stent restenosis is permitted
• • Patients with EF \< 30%
• • Serum creatinine level \>=2.0mg/dL or dependence on dialysis
• • Patients with left main stem stenosis (\> 50% visual estimate)