The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention
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ClinicalTrials.gov Identifier: NCT00699543 |
Recruitment Status
: Unknown
Verified December 2013 by Seoul National University Hospital.
Recruitment status was: Active, not recruiting
First Posted
: June 18, 2008
Last Update Posted
: December 17, 2013
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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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: Coroflex Please stent implantation Device: Taxus stent implantation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 915 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | July 2008 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: C
Coroflex Please stent implantation
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Device: Coroflex Please stent implantation
Use Coroflex Please stent in the treatment of coronary stenosis
Other Name: Coroflex Please stent
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Active Comparator: T
Taxus stent implantation
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Device: Taxus stent implantation
Use Taxus stent in the treatment of coronary stenosis
Other Name: Taxus stent
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- Clinically driven Target vessel Revascularization (TVR) [ Time Frame: 9 months. ]
- 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 ]
- Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR) [ Time Frame: 1, 4, 9, 12 months and 2, 3years ]
- Stent thrombosis [ Time Frame: 1, 4, 9, 12 months and 2, 3years ]
- In-stent binary restenosis by QCA [ Time Frame: 9 months ]
- In-stent and in-lesion late loss by QCA [ Time Frame: 9 months ]
- In-stent and in-lesion MLD and percentage diameter stenosis by QCA [ Time Frame: Immediately after the index procedure and at 9 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
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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)
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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
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General Exclusion Criteria
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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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699543
Study Chair: | Hyo-Soo Kim, MD, PhD | Seoul National University Hospital | |
Study Chair: | In-Ho Chae, MD, PhD | Seoul National University Bundang Hospital | |
Study Chair: | Seung-Ho Hur, MD, Ph | Keimyung University Dongsan Medical Center | |
Principal Investigator: | Tae-Jin Youn, MD, PhD | Seoul National University Bundang Hospital | |
Principal Investigator: | Soo-Joong Kim, MD, PhD | Kyunghee University Medical Center | |
Principal Investigator: | Keum-Soo Park, MD, PhD | Inha University Hospital | |
Principal Investigator: | Byung-Ok Kim, MD, PhD | Inje University Sang-gye Paik Hospital | |
Principal Investigator: | Min-Su Hyon, MD, PhD | Soon Chun Hyang University Hospital | |
Principal Investigator: | Sang-Wook Kim, MD, PhD | Chung-Ang University Hosptial, Chung-Ang University College of Medicine | |
Principal Investigator: | Jong-Seon Park, MD, PhD | Yeungnam University Hospital | |
Principal Investigator: | Doo-Il Kim, MD, PhD | Inje University | |
Principal Investigator: | Tae-Joon Cha, MD, PhD | Kosin University Gospel Hospital | |
Principal Investigator: | Sang-Gon Lee, MD, PhD | Ulsan University Hospital | |
Principal Investigator: | Hee-Kyoung Jeon, MD, PhD | Uijeongbu St. Mary's Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hyo-Soo, Kim, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00699543 History of Changes |
Other Study ID Numbers: |
ECO-PLEASANT |
First Posted: | June 18, 2008 Key Record Dates |
Last Update Posted: | December 17, 2013 |
Last Verified: | December 2013 |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |