Status:
TERMINATED
LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
Abbott
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2017
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01489761
Start Date
January 1 2012
End Date
February 14 2017
Last Update
February 24 2017
Active Locations (11)
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1
Gangwon National Univ. Hospital
Chuncheon, South Korea
2
Keimyung University Dongsan Medical Center
Daegu, South Korea
3
Kyungpook National university hospital
Daegu, South Korea
4
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea