The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention
NCT ID: NCT00699543
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
915 participants
INTERVENTIONAL
2008-07-31
2013-12-31
Brief Summary
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: To evaluate the clinical efficacy, angiographic outcomes, and safety of the new paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the treatment of coronary stenosis.
Study Design
: Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length \> 28mm)
Patient Enrollment
:915 patients enrolled at 13 centers in Korea.
Patient Follow-Up
:Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention. Investigator or designee may conduct follow-up as telephone contacts or office visits.
Primary Endpoint
:Clinically driven Target vessel Revascularization (TVR) at 9 months.
Secondary Endpoints
:A. Clinical safety and efficacy end points
1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
3. Stent thrombosis
B. Angiographic efficacy end points
1. in-stent binary restenosis by QCA
2. in-stent and in-lesion late loss by QCA
3. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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C
Coroflex Please stent implantation
Coroflex Please stent implantation
Use Coroflex Please stent in the treatment of coronary stenosis
T
Taxus stent implantation
Taxus stent implantation
Use Taxus stent in the treatment of coronary stenosis
Interventions
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Coroflex Please stent implantation
Use Coroflex Please stent in the treatment of coronary stenosis
Taxus stent implantation
Use Taxus stent in the treatment of coronary stenosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the CoroflexTM Please stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
3. Subject must have coronary artery stenosis (\>50% by visual estimate) with evidence of myocardial ischemia (e.g., stable, unstable angina, myocardial infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia.) or Subject must have significant coronary artery stenosis (\>70% by visual estimate)
1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm.
2. Target lesion(s) must be amenable for percutaneous coronary intervention
Exclusion Criteria
* Heparin
* Aspirin
* Both Clopidogrel and Ticlopidine
* Paclitaxel
* Stainless steel
* Contrast media(\*) (\*)Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
2. Systemic (intravenous) Paclitaxel use within 12 months.
3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
4. History of bleeding diathesis or known coagulopathy (including heparin- induced thrombocytopenia), or will refuse blood transfusions.
5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
6. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
7. 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).
8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
9. Patients with LVEF\<25% or those with cardiogenic shock
10. Patients with acute ST elevation myocardial infarction who requires primary PCI
11. Patients with acute ST elevation myocardial infarction within 48hrs
12. Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
1. Patients with significant left main stem stenosis which requires revascularization therapy
2. Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
3. Target lesions with bifurcating disease which require side branch stenting
18 Years
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Principal Investigators
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Hyo-Soo Kim, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
In-Ho Chae, MD, PhD
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Seung-Ho Hur, MD, Ph
Role: STUDY_CHAIR
Keimyung University Dongsan Medical Center
Tae-Jin Youn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Soo-Joong Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Keum-Soo Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Byung-Ok Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inje University Sang-gye Paik Hospital
Min-Su Hyon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Soon Chun Hyang University Hospital
Sang-Wook Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Jong-Seon Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yeungnam University Hospital
Doo-Il Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inje University
Tae-Joon Cha, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kosin University Gospel Hospital
Sang-Gon Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ulsan University Hospital
Hee-Kyoung Jeon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uijeongbu St. Mary's Hospital
References
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Seo JB, Kang SH, Hur SH, Park KW, Youn TJ, Park JS, Yang HM, Lee HY, Kang HJ, Koo BK, Bae JH, Kim SW, Moon KW, Choi JW, Lee SG, Chung WY, Kim SJ, Kim DI, Kim BO, Hyon MS, Park KS, Cha TJ, Yoo CW, Jeon HK, Kim HS. Randomized trial comparing the efficacy between different types of paclitaxel-eluting stents: the comparison of efficacy between COroflex PLEASe ANd Taxus stent (ECO-PLEASANT) randomized controlled trial. Am Heart J. 2013 May;165(5):733-43. doi: 10.1016/j.ahj.2013.02.009. Epub 2013 Mar 20.
Seo JB, Jeon HK, Park KW, Park JS, Bae JH, Kim SW, Moon KW, Choi JW, Lee SG, Chung WY, Youn TJ, Kim SJ, Kim DI, Kim BO, Hyon MS, Park KS, Cha TJ, Hwang HK, Hur SH, Kim HS. Efficacies of the new paclitaxel-eluting Coroflex Please stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please and Taxus (ECO-PLEASANT) trial: study rationale and design. Trials. 2009 Oct 23;10:98. doi: 10.1186/1745-6215-10-98.
Other Identifiers
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ECO-PLEASANT
Identifier Type: -
Identifier Source: org_study_id