Treatment of Bifurcation Lesions With The BIOTRONIK Pantera Lux Drug Eluting Balloo
- Conditions
- Patients with symptomatic ischaemic heart disease due to stenotic bifurcation lesions of de novo native coronary arteriesCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12610000770066
- Lead Sponsor
- BIOTRONIK Australia Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
Patient is an acceptable candidate for percutaneous coronary intervention (PCI) and emergent coronary artery bypass graft (CABG) surgery
Patient has clinical evidence of ischaemic heart disease or a positive functional study
Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
Patient or patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective investigational site
Patient agrees to comply with all specified follow-up evaluations
Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or prasugrel, paclitaxel, evrolimus or structurally related compounds, the delivery matrix Butyryltri-n-hexyl Citrate (BTHC), or a sensitivity to contrast media, which cannot be adequately pre-medicated
Platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, or a white blood cell (WBC) count < 3,000 cells/mm^3 within 7 days prior to the index procedure
Serum creatine level > 170 micromol/L or creatine clearance <60 ml/min. within 7 days prior to index procedure
Evidence of an acute MI within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having creatine kinase (CK) enzymes > 2X the laboratory upper limit of normal with the presence of an elevated creatine kinase-muscle and brain-type (CK-MB) (any amount above the laboratory upper limit of normal)
Previous stenting anywhere in the target vessel
Percutaneous coronary intervention (PCI) of a non-target vessel within 30 days prior to the procedure that results in any major adverse cardiac events (MACE)
Planned PCI of any vessel within 30 days post-procedure
Planned PCI of the target vessel within 6 months post-procedure
During the index procedure, the target lesion requires treatment with a device other than PTCA or cutting balloon prior to stent placement (including, but not limited to, atherectomy, laser, thrombectomy, etc.)
Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
History of a stroke or transient ischemic attack (TIA) within the prior 6 months
Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
History of bleeding diathesis or coagulopathy or will refuse blood transfusions
Concurrent medical condition with a life expectancy of less than 12 months
Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate lumen loss in the side branch as measured by quantitative coronary angiography (QCA)[9 months post-procedure]
- Secondary Outcome Measures
Name Time Method