To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs
John Hunter Hospital
Newcastle, New South Wales, Australia
In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES
Time frame: 9 months post-procedure.
All-cause and cardiac mortality
Time frame: 30 days, 9 months, 1, 2, 3, 4, and 5 year
Myocardial infarction: Q-wave and non Q-wave, cumulative and individual
Time frame: 30 days, 9 months, 1, 2, 3, 4, and 5 years
Major Adverse Cardiac Event (MACE) defined as a composite of death, MI (Q-wave or non Q-wave), emergent CABG, or target lesion revascularization by repeat PTCA or CABG
Time frame: Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure
Vascular complications from index procedure
Time frame: Up to hospital discharge
Rate of stent thrombosis, per ARC definition of definite and probable stent thrombosis further categorized as early, late or very late
Time frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure
Change in human anti-murine antibody (HAMA) plasma levels
Time frame: 30 day and 9 month follow-up compared to baseline
Device success, defined as attainment of <50% residual stenosis of the target lesion using the Combo Stent
Time frame: Index procedure
Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method
Time frame: Index procedure
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Procedure success defined as lesion success without the occurrence of in-hospital MACE
Time frame: Up to hospital discharge
Clinically (ischemia)-driven target lesion revascularization
Time frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years
Clinically (ischemia)-driven target vessel revascularization
Time frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years
In-stent and in-segment angiographic binary restenosis
Time frame: 9 months
In-stent and in-segment minimum lumen diameter (MLD)
Time frame: 9 months
In-stent, proximal and distal late lumen loss
Time frame: 9 months
Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up
Time frame: 9 months
Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR))
Time frame: 30 days, 9 months, 1, 2, 3, 4 and 5 years