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Sponsors and Collaborators: |
CardioVascular Research Foundation, Korea Medtronic Vascular |
Information provided by: | CardioVascular Research Foundation, Korea |
ClinicalTrials.gov Identifier: | NCT00418067 |
The purpose of this study is to establish the safety and long-term effectiveness of coronary stenting with the ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. the sirolimus-eluting balloon expandable stent (Cordis Johnson & Johnson, Warren, New Jersey) vs. the paclitaxel-eluting stent (Taxus liberte, Boston Scientific) in the treatment of coronary stenosis.
Condition | Intervention | Phase |
Coronary Artery Disease |
Device: Endeavor, Medtronic Device: Cypher, Cordis Device: Taxus Liberte, Boston Scientific |
Phase IV |
MedlinePlus related topics: | Coronary Artery Disease |
ChemIDplus related topics: | Paclitaxel Sirolimus |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Efficacy and the Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Versus PacliTaxel-Eluting Stent for Coronary Lesions |
Estimated Enrollment: | 2700 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2008 |
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent (Cypher, Cordis) and paclitaxel-eluting stent (Taxus, Boston Scientific) reduce neointimal formation and result in decrease of angiographic restenosis and target lesion revascularization at 1-3 years in the multicenter randomized clinical trials RAVEL, SIRIUS, and TAXUS I-VI.From these studies, the two leading drug-eluting stents (DESs) of the Cypher and Taxus have been widely and rapidly accepted as a standard treatment of coronary lesions.
Recently, randomized studies were conducted to reveal different outcomes of the different two DESs. These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes. A recent meta-analysis supported results of the former randomized studies. Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent.
With a recent approval of new DES, ABT-578-eluting stent (Endeavor, Medtronic, Minneapolis, MN), other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent. ABT-578 and sirolimus share some common structural and biological properties. The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline (PC)-coated ABT-578-eluting stent for the prevention of restenosis. The Endeavor ABT-578-eluting stent utilizes a cobalt alloy balloon-expandable stent (Driver; Medtronic) with a geometry similar to the stainless steel stent used in this preliminary study (S7; Medtronic). The Endeavor ABT-578-eluting stent also employees a PC strut surface coating as the drug delivery reservoir with a dose of 10 ug/mm of ABT-578. The Endeavor ABT-578-eluting stent, however, differs from the stent used in this experimental study by the addition of a drug-free PC coating to serve as a diffusion barrier to retard drug release from the polymer reservoir. Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14% and a late lumen loss of 0.3 mm with a low frequency of target lesion revascularization (1%). The clinical outcomes from the ENDEAVOR II (1,500 patients randomized to ABT-578 or bare metal stent) and the ENDEAVOR III (436 patients randomized 3:1 to ABT-578 or Cypher) trials as well as other ongoing studies showed efficacy of the PC-coated ABT-578-eluting stent. In ENDEAVOR III study, the Endeavor stent had larger late loss and higher binary restenosis in both the analysis segment and stented segment. In contrast, the TLR rates are not statistically different between the Endeavor (6.0%) and the Cypher (5.3%, p=1.0) stents. This result of this study raised several questions to warrant further randomized studies 1) is the angiographic superiority of Cypher stent applied to the more complex lesions, 2) why is the TLR rate similar in spite of significantly different angiographic outcomes, 3) which is better in the Endeavor and the Taxus stents, etc. The ENDEAVOR IV study is being conducted to compare the safety and efficacy of the Endeavor stent versus the Taxus stent. However, the inclusion of ENDEAVOR IV study was also limited that this study did not include all complex lesions. Because of the limitations of current ENDEAVOR series, a further large randomized study for the concurrent comparison of the three DESs in the treatment of real-world practice would be needed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The patient has a known hypersensitivity or contraindication to any of the following medications:
Contact: Seung-Jung Park, MD, PhD | (82-2)-3010-4812 | sjpark@amc.seoul.kr |
Contact: Duk-Woo Park, MD, PhD | (82-2)-3010-3995 | dwpark@amc.seoul.kr |
Korea, Republic of | |||||
Asan Medical Center | Recruiting | ||||
Seoul, Korea, Republic of, 138-736 | |||||
Contact: Seung-Jung Park, MD, PhD (82-2)-3010-4812 sjpark@amc.seoul.kr | |||||
Contact: Duk-Woo Park, MD, PhD (82-2)-3010-3995 dwpark@amc.seoul.kr | |||||
Principal Investigator: Seung-Jung Park, MD, PhD | |||||
Yonsei University Medical Center | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Yangsoo Jang, MD, PhD | |||||
Principal Investigator: Yang Soo Jang, MD, PhD | |||||
Seoul National University Hospital | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Hyo-Soo Kim, MD, PhD | |||||
Principal Investigator: Hyo-Soo Kim, MD, PhD | |||||
St.Mary's Catholic Medical Center | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Ki Bae Seung, MD, PhD | |||||
Principal Investigator: Ki Bae Seung, MD, PhD | |||||
Ajou University Hospital | Recruiting | ||||
Suwon, Korea, Republic of | |||||
Contact: Seung-Jae Tahk, MD, PhD | |||||
Principal Investigator: Seun-Jae Tahk, MD, PhD | |||||
Chonnam National University Hospital | Recruiting | ||||
Gwangju, Korea, Republic of | |||||
Contact: Myung Ho Jung, MD, PhD | |||||
Principal Investigator: Myung Ho Jeong, MD,PhD | |||||
Seoul National University Bundang Hospital | Recruiting | ||||
Seongnam, Korea, Republic of | |||||
Contact: In-Ho Chae, MD, PhD | |||||
Principal Investigator: In-Ho Chae, MD, PhD | |||||
Chungnam National University Hospital | Recruiting | ||||
Daejeon, Korea, Republic of | |||||
Contact: In-Whan Seong, MD, PhD | |||||
Principal Investigator: In-Whan Seong, MD, PhD | |||||
NHIC Ilsan Hospital | Recruiting | ||||
Ilsan, Korea, Republic of | |||||
Contact: Joo-Young Yang, MD, PhD | |||||
Principal Investigator: Joo-Young Yang, MD, PhD | |||||
Keimyung University Dongsan Medical Center | Recruiting | ||||
Daegu, Korea, Republic of | |||||
Contact: Seung-Ho Hur, MD, PhD | |||||
Principal Investigator: Seung-Ho Hur, MD, PhD | |||||
Korea University Hospital | Recruiting | ||||
Seoul, Korea, Republic of | |||||
Contact: Do-Sun Lim, MD, PhD | |||||
Principal Investigator: Do-Sun Lim, MD, PhD | |||||
Asan Medical Center | Recruiting | ||||
GangNeung, Korea, Republic of | |||||
Contact: Sang-Sig Cheong, MD, PhD | |||||
Principal Investigator: Sang-Sig Cheong, MD, PhD | |||||
Ulsan University Hospital | Recruiting | ||||
Ulsan, Korea, Republic of | |||||
Contact: Sang-Gon Lee, MD, PhD | |||||
Principal Investigator: Sang-Gon Lee, MD, PhD | |||||
Soonchunhyang University Bucheon Hospital | Recruiting | ||||
Bucheon, Korea, Republic of | |||||
Contact: Nae-Hee Lee, MD, PhD | |||||
Principal Investigator: Nae-Hee Lee, MD, PhD | |||||
Hallym University Sacred Heart Hospital | Recruiting | ||||
PyeongChon, Korea, Republic of | |||||
Contact: Young-Jin Choi, MD, PhD | |||||
Principal Investigator: Young-Jin Choi, MD, PhD | |||||
Daegu Catholic University Medical Center | Recruiting | ||||
Daegu, Korea, Republic of | |||||
Contact: Kee-Sik Kim, MD, PhD | |||||
Principal Investigator: Kee-Sik Kim, MD, PhD | |||||
Pusan Natioanal University Hospital | Recruiting | ||||
Pusan, Korea, Republic of | |||||
Contact: Taeg Jong Hong, MD, PhD | |||||
Principal Investigator: Taeg Jong Hong, MD, PhD | |||||
Kyungpook National University Hospital | Recruiting | ||||
Daegu, Korea, Republic of | |||||
Contact: Hun Sik Park, MD, PhD | |||||
Principal Investigator: Hun Sik Park, MD, PhD | |||||
Yonsei University Wonju Christian Hospital | Recruiting | ||||
Wonju, Korea, Republic of | |||||
Contact: Junghan Yoon, MD, PhD | |||||
Principal Investigator: Junghan Yoon, MD, PhD | |||||
Chonbuk National University Hospital | Recruiting | ||||
Jeonju, Korea, Republic of | |||||
Contact: Jae-Ki Ko, MD, PhD | |||||
Principal Investigator: Jae-Ki Ko, MD, PhD |
CardioVascular Research Foundation, Korea |
Medtronic Vascular |
Principal Investigator: | Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
Study ID Numbers: | 2006-0136 |
First Received: | January 3, 2007 |
Last Updated: | June 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00418067 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
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