Clinical trial NCT01489761: LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)
Official title: Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: long lesions
drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: Abbott
name: CardioVascular Research Foundation, Korea
First posted: 2011-12-12
Enrollment: 302
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 or Xience Alpine stent) for very long coronary lesions.

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 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.

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)

Primary outcomes:
measure: In-segment late luminal loss at 13 month follow-up
timeFrame: 13 month post stenting
Secondary outcomes:
measure: 1. All Death
timeFrame: 12 month clinical follow-up
measure: 2. Cardiac death
timeFrame: 12 month clinical follow-up
measure: 3. Myocardial infarction (MI)
timeFrame: 12 month clinical follow-up
measure: 4. Composite of death or MI
timeFrame: 12 month clinical follow-up
measure: 5. Composite of cardiac death or MI
timeFrame: 12 month clinical follow-up
measure: 6. Target vessel revascularization (ischemia-driven and clinically-driven)
timeFrame: 12 month clinical follow-up
measure: 7. Target lesion revascularization (ischemia-driven and clinically-driven)
timeFrame: 12 month clinical follow-up
measure: 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
timeFrame: 12 month clinical follow-up
measure: 9. Stent thrombosis (ARC criteria)
timeFrame: 12 month clinical follow-up
measure: 10. In-stent late loss
timeFrame: 13 month angiographic follow-up
measure: 11. In-stent and in-segment restenosis
timeFrame: 13 month angiographic follow-up
measure: 12. Angiographic pattern of restenosis
timeFrame: 13 month angiographic follow-up
measure: 13. Volume of intimal hyperplasia
timeFrame: 13 month IVUS follow-up
measure: 14. Incidence of late stent malapposition
timeFrame: 13 month IVUS follow-up
measure: 15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay
timeFrame: 2-3 days post stenting
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National university hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St.carollo Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: