Back to resultsEfficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing (EXCELLENT)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Everolimus-eluting stent (Xience or Promus)
Sirolimus-eluting stent (Cypher)
6-month clopidogrel therapy
12-month clopidogrel therapy
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Everolimus, Sirolimus, drug eluting stent, Clopidogrel
Eligibility Criteria
General Inclusion Criteria:
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant coronary artery stenosis (>50% by visual estimate)
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
- Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.
Angiographically Inclusion Criteria
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
General Exclusion Criteria:
- The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
- Systemic (intravenous) Sirolimus, everolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Patients who have received any stent implantation in the target vessel prior to enrollment.
- Patients with LVEF<25% or those with cardiogenic shock
- Patients with myocardial infarction within 72 hours
- Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).
Angiographic Exclusion Criteria
- Patients with significant left main coronary artery stenosis
- Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
- Target lesions with chronic total occlusion
- True bifurcation lesions requiring two stents
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
E6
S6
E12
S12
Arm Description
Everolimus-eluting stent 6-month clopidogrel therapy
Sirolimus-eluting stent 6-month clopidogrel therapy
Everolimus-eluting stent 12-month clopidogrel therapy
Sirolimus-eluting stent 12-month clopidogrel therapy
Outcomes
Primary Outcome Measures
In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy
Secondary Outcome Measures
All death
Cardiac death
Myocardial infarction
Target vessel revascularization (TVR) (all and ischemia-driven)
Target lesion revascularization (TLR) (all and ischemia-driven)
Stent thrombosis
Acute success (device, lesion, and procedure)
Bleeding
Cerebrovascular accident
In-stent LL at 9 months
Angiographic pattern of restenosis at 9-month angiographic follow-up
In-stent and in-segment % diameter stenosis (%DS) at 9 months
In-stent % volume obstruction (%VO) at 9 months
Incomplete stent apposition post index procedure
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
Full Information
NCT ID
NCT00698607
First Posted
June 15, 2008
Last Updated
June 28, 2010
Sponsor
Seoul National University Hospital
Collaborators
Abbott, Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00698607
Brief Title
Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
Acronym
EXCELLENT
Official Title
Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
Collaborators
Abbott, Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives
To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the treatment of coronary stenosis.
To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy.
Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm)
Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.
Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.
Primary Endpoint
In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy
Secondary Endpoint
All Death
Cardiac death
Myocardial infarction
Target vessel revascularization (TVR) (all and ischemia-driven)
Target lesion revascularization (TLR) (all and ischemia-driven)
Stent thrombosis
Acute success (device, lesion, and procedure)
Bleeding
Cerebrovascular accident
In-stent LL at 9 months
Angiographic pattern of restenosis at 9-month angiographic follow-up
In-stent and in-segment % diameter stenosis (%DS) at 9 months
In-stent % volume obstruction (%VO) at 9 months
Incomplete stent apposition post index procedure
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Everolimus, Sirolimus, drug eluting stent, Clopidogrel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1466 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E6
Arm Type
Experimental
Arm Description
Everolimus-eluting stent 6-month clopidogrel therapy
Arm Title
S6
Arm Type
Active Comparator
Arm Description
Sirolimus-eluting stent 6-month clopidogrel therapy
Arm Title
E12
Arm Type
Experimental
Arm Description
Everolimus-eluting stent 12-month clopidogrel therapy
Arm Title
S12
Arm Type
Active Comparator
Arm Description
Sirolimus-eluting stent 12-month clopidogrel therapy
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent (Xience or Promus)
Other Intervention Name(s)
Xience, Promus
Intervention Description
Use everolimus-eluting stent in the treatment of coronary stenosis
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting stent (Cypher)
Other Intervention Name(s)
Cypher
Intervention Description
Use sirolimus-eluting stent in the treatment of coronary stenosis
Intervention Type
Drug
Intervention Name(s)
6-month clopidogrel therapy
Other Intervention Name(s)
Plavix
Intervention Description
Use clopidogrel for 6 months
Intervention Type
Drug
Intervention Name(s)
12-month clopidogrel therapy
Other Intervention Name(s)
Plavix
Intervention Description
Use clopidogrel for 12 months
Primary Outcome Measure Information:
Title
In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
Time Frame
9 months
Title
Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All death
Time Frame
5 years
Title
Cardiac death
Time Frame
5 Years
Title
Myocardial infarction
Time Frame
5 years
Title
Target vessel revascularization (TVR) (all and ischemia-driven)
Time Frame
5 years
Title
Target lesion revascularization (TLR) (all and ischemia-driven)
Time Frame
5 years
Title
Stent thrombosis
Time Frame
5 years
Title
Acute success (device, lesion, and procedure)
Time Frame
Index procedure
Title
Bleeding
Time Frame
5 years
Title
Cerebrovascular accident
Time Frame
5 years
Title
In-stent LL at 9 months
Time Frame
9 months
Title
Angiographic pattern of restenosis at 9-month angiographic follow-up
Time Frame
9 months
Title
In-stent and in-segment % diameter stenosis (%DS) at 9 months
Time Frame
9 months
Title
In-stent % volume obstruction (%VO) at 9 months
Time Frame
9 months
Title
Incomplete stent apposition post index procedure
Time Frame
Index procedure
Title
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria:
Subject must be at least 18 years of age.
Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Subject must have significant coronary artery stenosis (>50% by visual estimate)
Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.
Angiographically Inclusion Criteria
Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
Target lesion(s) must be amenable for percutaneous coronary intervention
General Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
Systemic (intravenous) Sirolimus, everolimus use within 12 months.
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Patients who have received any stent implantation in the target vessel prior to enrollment.
Patients with LVEF<25% or those with cardiogenic shock
Patients with myocardial infarction within 72 hours
Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).
Angiographic Exclusion Criteria
Patients with significant left main coronary artery stenosis
Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
Target lesions with chronic total occlusion
True bifurcation lesions requiring two stents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yangsoo Jang, MD, PhD
Organizational Affiliation
Yonsei University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jung-Han Yoon, MD, PhD
Organizational Affiliation
Yonsei Univercity Wonju hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahn Tae-Hoon, MD, PhD
Organizational Affiliation
Gachon Kil Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hyun-Cheol Kwon, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
In-Ho Chae, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Young-Jin Choi, MD, PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyoo-Rok Han, MD, PhD
Organizational Affiliation
Kandong Sacred heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Si-Hoon Park, MD, PhD
Organizational Affiliation
Ewha Women's University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myeong-Ho Chung, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyuk-Moon Kwon, MD, PhD
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-Woon Chun, MD, PhD
Organizational Affiliation
National Health Insurance Service Ilsan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byung-Ok Kim, MD, PhD
Organizational Affiliation
Inje University Sanggye Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Do-Sun Lim, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taek-Jong Hong, MD, PhD
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo-Young Chung, MD, PhD
Organizational Affiliation
Borame Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Hun Chung, MD, PhD
Organizational Affiliation
Hallym University Kangnam Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
28 Yongon Dong, Jongro Gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32588238
Citation
Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.
Results Reference
derived
PubMed Identifier
31642213
Citation
Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.
Results Reference
derived
PubMed Identifier
30475845
Citation
Jang JY, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Jang Y. Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome. PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.
Results Reference
derived
PubMed Identifier
23456359
Citation
Ko YG, Shin DH, Kim JS, Kim BK, Choi D, Hong MK, Gwon HC, Ahn T, Chae IH, Yoon JH, Kim HS, Jang Y; EXCELLENT investigators. Comparison of neointimal hyperplasia and peri-stent vascular remodeling after implantation of everolimus-eluting versus sirolimus-eluting stents: intravascular ultrasound results from the EXCELLENT study. Int J Cardiovasc Imaging. 2013 Aug;29(6):1229-36. doi: 10.1007/s10554-013-0199-5. Epub 2013 Mar 3.
Results Reference
derived
PubMed Identifier
22179532
Citation
Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.
Results Reference
derived
PubMed Identifier
22018294
Citation
Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Jo SH, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Gwon HC, Jang YS, Kim HS. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol. 2011 Oct 25;58(18):1844-54. doi: 10.1016/j.jacc.2011.07.031.
Results Reference
derived
PubMed Identifier
19376305
Citation
Park KW, Yoon JH, Kim JS, Hahn JY, Cho YS, Chae IH, Gwon HC, Ahn T, Oh BH, Park JE, Shim WH, Shin EK, Jang YS, Kim HS. Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: study design and rationale of a Korean multicenter prospective randomized trial. Am Heart J. 2009 May;157(5):811-817.e1. doi: 10.1016/j.ahj.2009.02.008.
Results Reference
derived
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Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
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