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

Coronary Artery Disease Clinical Trial

— LONG-DES-III  

Official title:

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078038
• Other study ID #: 2008-0250
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2009
• Last updated: August 7, 2012
• Start date: June 2008
• Est. completion date: August 2010

Study information

• Verified date: August 2012
• 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 sirolimus versus everolimus-eluting stent implantation 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 III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• 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:
• Cypher
Sirolimus-eluting stent implantation
• Xience V
Everolimus-eluting Stent implantation

Locations

Country	Name	City	State
Korea, Republic of	Sam Anyang Hospital	Anyang
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Busan Paik Hospital	Busan
Korea, Republic of	St.Mary's Catholic Medical Center	Busan
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	St.Mary's Catholic Medical Center	Cheongju
Korea, Republic of	Gangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	GangNeung
Korea, Republic of	Gwangju Christian Hospital	Gwangju
Korea, Republic of	Dongguk University Hospital	Gyongju
Korea, Republic of	St.Mary's Catholic Medical Center	Inchon
Korea, Republic of	Jeju Hanla Hospital	Jeju
Korea, Republic of	Gyeongsang Uniservity Hospital	Jinju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	St.Mary's Catholic Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

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 follow-up	No
Secondary	All Death		one month	Yes
Secondary	Cardiac death		1 year	Yes
Secondary	Myocardial infarction (MI)		1 year	Yes
Secondary	Composite of death or MI		1 year	Yes
Secondary	Composite of cardiac death or MI		1 year	Yes
Secondary	Target vessel revascularization (ischemia-driven and clinically-driven)		1 year	No
Secondary	Target lesion revascularization (ischemia-driven and clinically-driven)		1 year	No
Secondary	Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)		1 year	Yes
Secondary	Stent thrombosis (ARC criteria)		1 year	Yes
Secondary	In-stent late loss at 9 month angiographic follow-up		at 9 month angiographic follow-up	No
Secondary	In-stent and in-segment restenosis at 9 month angiographic follow-up		at 9 month angiographic follow-up	No
Secondary	Angiographic pattern of restenosis at 9 month angiographic follow-up		at 9 month angiographic follow-up	No
Secondary	Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)		at 9 month angiographic follow-up	No
Secondary	Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)		at 9 month angiographic follow-up	No
Secondary	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.	At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.	3 days in average	No
Secondary	All Death		9 months	Yes
Secondary	All Death		one year	Yes
Secondary	Cardiac death		one month	Yes
Secondary	Cardiac death		9 months	Yes
Secondary	Myocardial infarction (MI)		one month	Yes
Secondary	Myocardial infarction (MI)		9 months	Yes
Secondary	Composite of death or MI		one month	Yes
Secondary	Composite of death or MI		9 months	Yes
Secondary	Composite of cardiac death or MI		one month	Yes
Secondary	Composite of cardiac death or MI		9 months	Yes
Secondary	Target vessel revascularization (ischemia-driven and clinically-driven)		one month	No
Secondary	Target vessel revascularization (ischemia-driven and clinically-driven)		9 months	No
Secondary	Target lesion revascularization (ischemia-driven and clinically-driven)		one month	No
Secondary	Target lesion revascularization (ischemia-driven and clinically-driven)		9 months	No
Secondary	Stent thrombosis (ARC criteria)		one month	Yes
Secondary	Stent thrombosis (ARC criteria)		9 months	Yes