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

Coronary Artery Disease Clinical Trial

— PIPA  

Official title:

Comparison of the Efficacy and Safety of Paclitaxel-Eluting CoroflexTM Please Stent Versus Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995423
• Other study ID #: 2007-0497
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2009
• Last updated: August 17, 2010
• Start date: April 2008
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CoroflexTM Please
highly flexible CoroflexTM Please-Stent
• Paclitaxel-eluting stent
Paclitaxel-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	GangNeung
Korea, Republic of	Kwangju Christian Hospital	Kwangju
Korea, Republic of	Hallym University Sacred Heart Hospital	PyeongChon
Korea, Republic of	Asan Medical Center	Seoul
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

Sponsors (1)

Lead Sponsor	Collaborator
CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late lumen loss by quantitative coronary angiographic measurements		9 months	Yes
Secondary	All Death		12 months	Yes
Secondary	Cardiac death		12 months	Yes
Secondary	Myocardial infarction		12 month	Yes
Secondary	Target vessel revascularization (all and ischemia-driven)		12 month	Yes
Secondary	Target lesion revascularization (all and ischemia-driven)		12 months	Yes
Secondary	Stent thrombosis (by ARC definition)		12 months	Yes
Secondary	In-stent late loss at 9 month angiographic follow-up		12 months	Yes
Secondary	Binary restenosis in both in-stent and in-segment		9 month	Yes
Secondary	Angiographic pattern of restenosis		9 months	Yes
Secondary	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	Yes