The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Device: Coroflex Please stent implantation; Device: Taxus stent implantation	Phase 3

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: C; Coroflex Please stent implantation	Device: Coroflex Please stent implantation; Use Coroflex Please stent in the treatment of coronary stenosis; Other Name: Coroflex Please stent
Active Comparator: T; Taxus stent implantation	Device: Taxus stent implantation; Use Taxus stent in the treatment of coronary stenosis; Other Name: Taxus stent

Outcome Measures

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Primary Outcome Measures :

1. Clinically driven Target vessel Revascularization (TVR) [ Time Frame: 9 months. ]

Secondary Outcome Measures :

1. 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 ]
2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR) [ Time Frame: 1, 4, 9, 12 months and 2, 3years ]
3. Stent thrombosis [ Time Frame: 1, 4, 9, 12 months and 2, 3years ]
4. In-stent binary restenosis by QCA [ Time Frame: 9 months ]
5. In-stent and in-lesion late loss by QCA [ Time Frame: 9 months ]
6. In-stent and in-lesion MLD and percentage diameter stenosis by QCA [ Time Frame: Immediately after the index procedure and at 9 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

• General Inclusion Criteria

  1. Subject must be at least 18 years of age.
  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)

• Angiographic Inclusion Criteria

  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

• General Exclusion Criteria

  1. 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.
  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.

• Angiographic Exclusion Criteria

  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

Contacts and Locations

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Sponsors and Collaborators

Seoul National University Hospital

B. Braun Melsungen AG

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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