Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: CoroflexTM Please; Device: Paclitaxel-eluting stent

• Registration Number: NCT00995423
• Lead Sponsor: CardioVascular Research Foundation, Korea

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CoroflexTM	CoroflexTM Please	highly flexible CoroflexTM Please-Stent features
TAXUS	Paclitaxel-eluting stent	Paclitaxel-eluting stent

Primary Outcome Measures

Name	Time	Method
In-segment late lumen loss by quantitative coronary angiographic measurements	9 months

Secondary Outcome Measures

Name	Time	Method
All Death	12 months
Cardiac death	12 months
Myocardial infarction	12 month
Target vessel revascularization (all and ischemia-driven)	12 month
Target lesion revascularization (all and ischemia-driven)	12 months
Stent thrombosis (by ARC definition)	12 months
In-stent late loss at 9 month angiographic follow-up	12 months
Binary restenosis in both in-stent and in-segment	9 month
Angiographic pattern of restenosis	9 months
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	during the hospital stay

Trial Locations

Locations (9)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 PyeongChon, Korea, Republic of

Kwangju Christian Hospital; 🇰🇷 Kwangju, Korea, Republic of

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Veterans Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of