Clinical trial NCT00995423: Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent
Official title: Comparison of the Efficacy and Safety of Paclitaxel-Eluting CoroflexTM Please Stent Versus Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
stent
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether the outcome of treatment with CoroflexTM Please stent is not inferior to the outcome of treatment with TAXUS stent.

Detailed description: To establish the effectiveness and the safety of coronary stenting with the newly developed paclitaxel-eluting balloon expandable stent (CoroflexTM Please stent, B. Bran, Melsungen, Germany), compared to the conventional paclitaxel-eluting balloon expandable stent (TAXUS stent, Boston scientific) in the treatment of coronary stenosis.

Eligibility criteria: Inclusion Criteria:

* The patient must be at least 18 years of age
* Significant de novo coronary artery stenosis (\>50% by visual estimation)
* Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patents with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications:

  * Heparin
  * Aspirin
  * Both Clopidogrel and TIclopidine
  * Sirolimus, paclitaxel
  * Stainless steel and/or
  * Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled)
* Systemic (intravenous) Sirolimus or 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
* Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL
* An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 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 EF\<25%
* Cardiogenic shock at entry
* Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
* Creatinine level \> 3.0mg/dL or dependence on dialysis
* Patients with left main stem stenosis (\>50% by visual estimate)

Primary outcomes:
measure: In-segment late lumen loss by quantitative coronary angiographic measurements
timeFrame: 9 months
Secondary outcomes:
measure: All Death
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 month
measure: Target vessel revascularization (all and ischemia-driven)
timeFrame: 12 month
measure: Target lesion revascularization (all and ischemia-driven)
timeFrame: 12 months
measure: Stent thrombosis (by ARC definition)
timeFrame: 12 months
measure: In-stent late loss at 9 month angiographic follow-up
timeFrame: 12 months
measure: Binary restenosis in both in-stent and in-segment
timeFrame: 9 month
measure: Angiographic pattern of restenosis
timeFrame: 9 months
measure: Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
timeFrame: during the hospital stay
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: GangNeung
country: Korea, Republic of
facility: Asan Medical Center
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: PyeongChon
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Seung-Jung Park Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: