The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Coroflex Please stent implantation
Taxus stent implantation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion 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 CoroflexTM Please stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- 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)
Angiographic Inclusion Criteria
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
Exclusion Criteria
General Exclusion Criteria
The patient has a known hypersensitivity or contraindication to any of the following medications:
- 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.
- Systemic (intravenous) Paclitaxel 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.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 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 with LVEF<25% or those with cardiogenic shock
- Patients with acute ST elevation myocardial infarction who requires primary PCI
- Patients with acute ST elevation myocardial infarction within 48hrs
- Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
Angiographic Exclusion Criteria
- Patients with significant left main stem stenosis which requires revascularization therapy
- Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
- Target lesions with bifurcating disease which require side branch stenting
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
C
T
Arm Description
Coroflex Please stent implantation
Taxus stent implantation
Outcomes
Primary Outcome Measures
Clinically driven Target vessel Revascularization (TVR)
Secondary Outcome Measures
Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
Stent thrombosis
In-stent binary restenosis by QCA
In-stent and in-lesion late loss by QCA
In-stent and in-lesion MLD and percentage diameter stenosis by QCA
Full Information
NCT ID
NCT00699543
First Posted
June 16, 2008
Last Updated
December 15, 2013
Sponsor
Seoul National University Hospital
Collaborators
B. Braun Melsungen AG
1. Study Identification
Unique Protocol Identification Number
NCT00699543
Brief Title
The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention
Official Title
The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention: Comparison or Efficacy Between COroflex PLEASe ANd TaxusTM Stent
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
Collaborators
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives
: 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
Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
Stent thrombosis
B. Angiographic efficacy end points
in-stent binary restenosis by QCA
in-stent and in-lesion late loss by QCA
in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
915 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C
Arm Type
Experimental
Arm Description
Coroflex Please stent implantation
Arm Title
T
Arm Type
Active Comparator
Arm Description
Taxus stent implantation
Intervention Type
Device
Intervention Name(s)
Coroflex Please stent implantation
Other Intervention Name(s)
Coroflex Please stent
Intervention Description
Use Coroflex Please stent in the treatment of coronary stenosis
Intervention Type
Device
Intervention Name(s)
Taxus stent implantation
Other Intervention Name(s)
Taxus stent
Intervention Description
Use Taxus stent in the treatment of coronary stenosis
Primary Outcome Measure Information:
Title
Clinically driven Target vessel Revascularization (TVR)
Time Frame
9 months.
Secondary Outcome Measure Information:
Title
Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
Time Frame
1, 4, 9, 12 months and 2, 3years
Title
Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
Time Frame
1, 4, 9, 12 months and 2, 3years
Title
Stent thrombosis
Time Frame
1, 4, 9, 12 months and 2, 3years
Title
In-stent binary restenosis by QCA
Time Frame
9 months
Title
In-stent and in-lesion late loss by QCA
Time Frame
9 months
Title
In-stent and in-lesion MLD and percentage diameter stenosis by QCA
Time Frame
Immediately after the index procedure and at 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 CoroflexTM Please stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
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)
Angiographic Inclusion Criteria
Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm.
Target lesion(s) must be amenable for percutaneous coronary intervention
Exclusion Criteria
General Exclusion Criteria
The patient has a known hypersensitivity or contraindication to any of the following medications:
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.
Systemic (intravenous) Paclitaxel 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.
An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 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 with LVEF<25% or those with cardiogenic shock
Patients with acute ST elevation myocardial infarction who requires primary PCI
Patients with acute ST elevation myocardial infarction within 48hrs
Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
Angiographic Exclusion Criteria
Patients with significant left main stem stenosis which requires revascularization therapy
Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
Target lesions with bifurcating disease which require side branch stenting
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
In-Ho Chae, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seung-Ho Hur, MD, Ph
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tae-Jin Youn, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo-Joong Kim, MD, PhD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keum-Soo Park, MD, PhD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byung-Ok Kim, MD, PhD
Organizational Affiliation
Inje University Sang-gye Paik Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min-Su Hyon, MD, PhD
Organizational Affiliation
Soon Chun Hyang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Wook Kim, MD, PhD
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong-Seon Park, MD, PhD
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doo-Il Kim, MD, PhD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae-Joon Cha, MD, PhD
Organizational Affiliation
Kosin University Gospel Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Gon Lee, MD, PhD
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hee-Kyoung Jeon, MD, PhD
Organizational Affiliation
Uijeongbu St. Mary's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23622910
Citation
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.
Results Reference
derived
PubMed Identifier
19849864
Citation
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.
Results Reference
derived
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The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention
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