Coronary Artery Disease
Conditions
Keywords
long lesions, drug eluting stents
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.
Interventions
DEVICEpercutaneous coronary intervention
drug eluting stent implantation
Sponsors
Abbott
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late luminal loss at 13 month follow-up | 13 month post stenting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2. Cardiac death | 12 month clinical follow-up | — |
| 3. Myocardial infarction (MI) | 12 month clinical follow-up | — |
| 4. Composite of death or MI | 12 month clinical follow-up | — |
| 5. Composite of cardiac death or MI | 12 month clinical follow-up | — |
| 6. Target vessel revascularization (ischemia-driven and clinically-driven) | 12 month clinical follow-up | — |
| 7. Target lesion revascularization (ischemia-driven and clinically-driven) | 12 month clinical follow-up | — |
| 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) | 12 month clinical follow-up | — |
| 1. All Death | 12 month clinical follow-up | — |
| 10. In-stent late loss | 13 month angiographic follow-up | — |
| 11. In-stent and in-segment restenosis | 13 month angiographic follow-up | — |
| 12. Angiographic pattern of restenosis | 13 month angiographic follow-up | — |
| 13. Volume of intimal hyperplasia | 13 month IVUS follow-up | sub-study |
| 14. Incidence of late stent malapposition | 13 month IVUS follow-up | sub-study |
| 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 | 2-3 days post stenting | — |
| 9. Stent thrombosis (ARC criteria) | 12 month clinical follow-up | — |
Countries
South Korea
Outcome results
None listed