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

Purpose

This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (RESOLUTE INTEGRITY stent) or everolimus-eluting stent (XIENCE PRIME stent) for very long coronary lesions.

Condition	Intervention	Phase
Coronary Artery Disease	Device: percutaneous coronary intervention ((RESOLUTE INTEGRITY stent) (XIENCE PRIME stent)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

In-segment late luminal loss at 13 month follow-up [ Time Frame: 13 month post stenting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1. All Death [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
2. Cardiac death [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
3. Myocardial infarction (MI) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
4. Composite of death or MI [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
5. Composite of cardiac death or MI [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
6. Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: No ]
7. Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: No ]
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
9. Stent thrombosis (ARC criteria) [ Time Frame: 12 month clinical follow-up ] [ Designated as safety issue: Yes ]
10. In-stent late loss [ Time Frame: 13 month angiographic follow-up ] [ Designated as safety issue: No ]
11. In-stent and in-segment restenosis [ Time Frame: 13 month angiographic follow-up ] [ Designated as safety issue: No ]
12. Angiographic pattern of restenosis [ Time Frame: 13 month angiographic follow-up ] [ Designated as safety issue: No ]
13. Volume of intimal hyperplasia [ Time Frame: 13 month IVUS follow-up ] [ Designated as safety issue: No ]
sub-study
14. Incidence of late stent malapposition [ Time Frame: 13 month IVUS follow-up ] [ Designated as safety issue: No ]
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 [ Time Frame: 2-3 days post stenting ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	January 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: zotarolimus-eluting stent (RESOLUTE INTEGRITY stent)	Device: percutaneous coronary intervention ((RESOLUTE INTEGRITY stent) (XIENCE PRIME stent) drug eluting stent implantation
Experimental: everolimus-eluting stent (XIENCE PRIME stent)	Device: percutaneous coronary intervention ((RESOLUTE INTEGRITY stent) (XIENCE PRIME stent) drug eluting stent implantation

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 stent) or everolimus-eluting stent (XIENCE PRIME stent) by the stratified randomization method.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient must be at least 18 years of age
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489761

Contacts

Contact: Seung-Jung Park, MD, PhD	82-2-3010-4812	sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD	82-2-3010-3995	dwpark@amc.seoul.kr

Locations

Korea, Republic of
8 Locations	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Duk-Woo Park

Abbott

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

Asan Medical Center

More Information

No publications provided

Responsible Party:	Duk-Woo Park, MD,PhD, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT01489761 History of Changes
Other Study ID Numbers:	CVRF2011-9
Study First Received:	December 8, 2011
Last Updated:	April 26, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by CardioVascular Research Foundation, Korea:

long lesions
drug eluting stents

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013