Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions

Coronary Artery Disease Clinical Trial

— LONG-DES-V  

Official title:

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186120
• Other study ID #: 2010-0036
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2010
• Last updated: November 5, 2013
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.

Description:

Following angiography, patients with significant diameter stenosis >50% and lesion length(> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 25mm, which requiring single or multiple long stent placement (>=28mm)

• Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction

• 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, sirolimus, 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, non-target vessel ISR is permitted) Patients with EF<30%.

• Serum creatinine level >=3.0mg/dL or dependence on dialysis.

• Patients with left main stem stenosis (>50% by visual estimate).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Biolimus A9-eluting stent
drug-eluting stent
• Everolimus-eluting stent
drug-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital, Buchen	Bucheon
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Kangwon National University Hospital	Chooncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	NHIC Ilsan Hospital	Ilsan
Korea, Republic of	Dong-A University Medical Center	Pusan
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University, Kangnam St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	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		9 month angiographic follow-up	No
Secondary	Death (all-cause and cardiac)		1 year	Yes
Secondary	Myocardial infarction		1 year	Yes
Secondary	stent thrombosis(ARC criteria)		1 year	Yes
Secondary	target-lesion revascularization		1 year	No
Secondary	target-vessel revascularization		1 year	No
Secondary	Procedural success		at 1 day	No
Secondary	Death (all-cause and cardiac)		one month	Yes
Secondary	Death (all-cause and cardiac)		9 months	Yes
Secondary	Myocardial infarction		one month	Yes
Secondary	Myocardial infarction		9 months	Yes
Secondary	Composite of death or MI		one month	Yes
Secondary	Composite of death or MI		9 months	Yes
Secondary	Composite of death or MI		1 year	Yes
Secondary	Composite of cardiac death or MI		one month	Yes
Secondary	Composite of cardiac death or MI		9 months	Yes
Secondary	Composite of cardiac death or MI		1 year	Yes
Secondary	target-lesion revascularization		one month	No
Secondary	target-lesion revascularization		9 months	No
Secondary	target-vessel revascularization		one month	No
Secondary	target-vessel revascularization		9 months	No
Secondary	stent thrombosis(ARC criteria)		one month	Yes
Secondary	stent thrombosis(ARC criteria)		9 months	Yes
Secondary	In-stent late loss		9 month angiographic follow-up	No
Secondary	8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)		12 months	Yes
Secondary	In-stent and in-segment restenosis		9 month angiographic follow-up	No
Secondary	Angiographic pattern of restenosis		9 month angiographic follow-up	No