None listed
Conditions
Brief summary
The study is intended to assess the feasibility and safety of the BIOTRONIK drug-eluting balloon Pantera Lux for the treatment of narrowing cardiac arteries where those arteries branch out into side arms. The study will assess both immediate success of this treatment as well as whether those arteries remain open after 9 months.
Interventions
Treatment of bifurcation lesions with a drug-eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon. The drug-eluting balloon is coated with 3 micrograms of paclitaxel per mm^2 of balloon surface. The balloon is inserted into the femoral artery and advanced into the coronary arteries. Once the target lesion is identified using X-ray and a dye (angiogram), the balloon is advanced to the narrowed portion of the vessel and inflated for about 30 seconds thus releasing the drug (paclit
Treatment of bifurcation lesions with a drug-eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon. The drug-eluting balloon is coated with 3 micrograms of paclitaxel per mm^2 of balloon surface. The balloon is inserted into the femoral artery and advanced into the coronary arteries. Once the target lesion is identified using X-ray and a dye (angiogram), the balloon is advanced to the narrowed portion of the vessel and inflated for about 30 seconds thus releasing the drug (paclitaxel) into the surrounding tissue. The balloon is removed immediately after deflation. Another angiogram is performed to confirm restoration of blood flow. This is a one-off procedure and takes about 45 minutes.
Sponsors
BIOTRONIK Australia Pty. Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed