Bare Metal BifuRcAtion SteNt Clinical Trial in Humans (IP088) With Coronary Stenosis At or Near a Vessel Bifurcation - Safety at 30-Days
- Conditions
- Stenosis of Coronary ArteriesCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12608000072314
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Patient is =/> 18 years old
Acceptable candidate for Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG)
Clinical evidence of ischemic heart disease
Female patients with negative pregnancy test
Informed Consent Obtained
Agrees to comply with follow-up evaluations
Single de novo bifurcation lesion in a native coronary artery with specific dimensions
Stenosis =/> 50% and < 100%
Thrombolysis in Myocardial Infarction (TIMI) flow =/> 2
Hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum
Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3
WBC < 3,000 cells/mm3
Serum creatinine level > 170 micromol/L
Evidence of MI within 72 hours of intended trial procedure
Previous stenting in Target Vessel
LVEF < 30%
History of stroke or TIA within 6 months
History of bleeding diathesis or coagulopathy or refusal of blood transfusion
Specific target lesion morphology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target vessel revascularization (TVR)[30 Days post-procedure]
- Secondary Outcome Measures
Name Time Method A composite of cardiac death, target vessel MI and clinically driven TVR[6, 9, and 12 months post-procedure]