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

Coronary Artery Disease Clinical Trial

Official title:

Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01489761
• Other study ID #: CVRF2011-9
• Status: Terminated
• Phase: Phase 4
• First received: December 8, 2011
• Last updated: February 23, 2017
• Start date: January 2012
• Est. completion date: February 14, 2017

Study information

• Verified date: February 2017
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 302
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• percutaneous coronary intervention
drug eluting stent implantation

Locations

Country	Name	City	State
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National university hospital	Daegu
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Ilsan
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	St.carollo Hospital	Suncheon
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (3)

Lead Sponsor	Collaborator
Seung-Jung Park	Abbott, CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late luminal loss at 13 month follow-up		13 month post stenting
Secondary	1. All Death		12 month clinical follow-up
Secondary	2. Cardiac death		12 month clinical follow-up
Secondary	3. Myocardial infarction (MI)		12 month clinical follow-up
Secondary	4. Composite of death or MI		12 month clinical follow-up
Secondary	5. Composite of cardiac death or MI		12 month clinical follow-up
Secondary	6. Target vessel revascularization (ischemia-driven and clinically-driven)		12 month clinical follow-up
Secondary	7. Target lesion revascularization (ischemia-driven and clinically-driven)		12 month clinical follow-up
Secondary	8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)		12 month clinical follow-up
Secondary	9. Stent thrombosis (ARC criteria)		12 month clinical follow-up
Secondary	10. In-stent late loss		13 month angiographic follow-up
Secondary	11. In-stent and in-segment restenosis		13 month angiographic follow-up
Secondary	12. Angiographic pattern of restenosis		13 month angiographic follow-up
Secondary	13. Volume of intimal hyperplasia	sub-study	13 month IVUS follow-up
Secondary	14. Incidence of late stent malapposition	sub-study	13 month IVUS follow-up
Secondary	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