Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent (PIPA)

CardioVascular Research Foundation, Korea

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Paclitaxel-eluting stent

Device: CoroflexTM Please

Study type

Interventional

Funder types

Other

Identifiers

NCT00995423

2007-0497

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)