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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Biolimus A9-eluting stent; Device: Everolimus-eluting stent

• Registration Number: NCT01186120
• Lead Sponsor: Seung-Jung Park

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2013-05
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biolimus A9-eluting stent	Biolimus A9-eluting stent	NOBORI stent
Everolimus-eluting stent	Everolimus-eluting stent	PROMUS ELEMENTE stent

Primary Outcome Measures

Name	Time	Method
In-segment late luminal loss	9 month angiographic follow-up

Secondary Outcome Measures

Name	Time	Method
In-stent late loss	9 month angiographic follow-up
Composite of cardiac death or MI	1 year
Death (all-cause and cardiac)	9 months
target-lesion revascularization	9 months
target-vessel revascularization	9 months
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)	12 months
In-stent and in-segment restenosis	9 month angiographic follow-up
Angiographic pattern of restenosis	9 month angiographic follow-up
stent thrombosis(ARC criteria)	9 months
Procedural success	at 1 day
Myocardial infarction	9 months
Composite of death or MI	1 year

Trial Locations

Locations (11)

Dong-A University Medical Center; 🇰🇷 Pusan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Soonchunhyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

NHIC Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Soonchunhyang University Hospital, Buchen; 🇰🇷 Bucheon, Korea, Republic of

Catholic University, Kangnam St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chooncheon, Korea, Republic of