Status:
UNKNOWN
The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- General Inclusion Criteria
- 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)
- Angiographic Inclusion Criteria
- 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
- Exclusion Criteria
- General Exclusion Criteria
- 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
- Patients with acute ST elevation myocardial infarction who requires primary PCI
- Patients with acute ST elevation myocardial infarction within 48hrs
- Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
- Angiographic Exclusion Criteria
- Patients with significant left main stem stenosis which requires revascularization therapy
- Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
- Target lesions with bifurcating disease which require side branch stenting
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
915 Patients enrolled
Trial Details
Trial ID
NCT00699543
Start Date
July 1 2008
End Date
December 1 2013
Last Update
December 17 2013
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