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

NCT00699543 | Unknown Phase 3 DMC

• 1 other identifier: ECO-PLEASANT
• Study Type: interventional
• Target: 915
• Locations: 0 countries
• Sites: N/A

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. 1.Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
2. 2.Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
3. 3.Stent thrombosis
4. 4.in-stent binary restenosis by QCA
5. 5.in-stent and in-lesion late loss by QCA
6. 6.in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Clinically driven Target vessel Revascularization (TVR)

  9 months.

Secondary Outcomes (6)

• Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)

  1, 4, 9, 12 months and 2, 3years

• Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)

  1, 4, 9, 12 months and 2, 3years

• Stent thrombosis

  1, 4, 9, 12 months and 2, 3years

• In-stent binary restenosis by QCA

  9 months

• In-stent and in-lesion late loss by QCA

  9 months

Study Arms (2)

C

EXPERIMENTAL

Coroflex Please stent implantation

Device: Coroflex Please stent implantation

T

ACTIVE COMPARATOR

Taxus stent implantation

Device: Taxus stent implantation

Interventions

Coroflex Please stent implantation DEVICE

Use Coroflex Please stent in the treatment of coronary stenosis

Also known as: Coroflex Please stent

C

Taxus stent implantation DEVICE

Use Taxus stent in the treatment of coronary stenosis

Also known as: Taxus stent

T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• B. Braun Melsungen AG: collaborator

Related Publications (2)

• 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.

  PMID: 23622910 DERIVED

• 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.

  PMID: 19849864 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12