Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01078038
• Date of registration: 18/10/2009
• Primary sponsor: Seung-Jung Park
• Public title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III) LONG-DES-III
• Scientific title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent
• Date of first enrolment: June 2008
• Target sample size: 451
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01078038
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Seung-Jung Park, MD, PhD
• Affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Key inclusion & exclusion 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 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Device: Cypher

Device: Xience V

Primary Outcome(s)

In-segment late luminal loss [Time Frame: 9 month follow-up]

Secondary Outcome(s)

All Death [Time Frame: 9 months]

All Death [Time Frame: one month]

All Death [Time Frame: one year]

Angiographic pattern of restenosis at 9 month angiographic follow-up [Time Frame: at 9 month angiographic follow-up]

Cardiac death [Time Frame: 1 year]

Cardiac death [Time Frame: 9 months]

Cardiac death [Time Frame: one month]

Composite of cardiac death or MI [Time Frame: 1 year]

Composite of cardiac death or MI [Time Frame: 9 months]

Composite of cardiac death or MI [Time Frame: one month]

Composite of death or MI [Time Frame: 1 year]

Composite of death or MI [Time Frame: 9 months]

Composite of death or MI [Time Frame: one month]

In-stent and in-segment restenosis at 9 month angiographic follow-up [Time Frame: at 9 month angiographic follow-up]

In-stent late loss at 9 month angiographic follow-up [Time Frame: at 9 month angiographic follow-up]

Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [Time Frame: at 9 month angiographic follow-up]

Myocardial infarction (MI) [Time Frame: 1 year]

Myocardial infarction (MI) [Time Frame: 9 months]

Myocardial infarction (MI) [Time Frame: one month]

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: 3 days in average]

Stent thrombosis (ARC criteria) [Time Frame: 1 year]

Stent thrombosis (ARC criteria) [Time Frame: 9 months]

Stent thrombosis (ARC criteria) [Time Frame: one month]

Target lesion revascularization (ischemia-driven and clinically-driven) [Time Frame: 1 year]

Target lesion revascularization (ischemia-driven and clinically-driven) [Time Frame: 9 months]

Target lesion revascularization (ischemia-driven and clinically-driven) [Time Frame: one month]

Target vessel revascularization (ischemia-driven and clinically-driven) [Time Frame: 1 year]

Target vessel revascularization (ischemia-driven and clinically-driven) [Time Frame: 9 months]

Target vessel revascularization (ischemia-driven and clinically-driven) [Time Frame: one month]

Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [Time Frame: 1 year]

Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [Time Frame: at 9 month angiographic follow-up]

Secondary ID(s)

2008-0250

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CardioVascular Research Foundation, Korea