Coronary Artery Lesions
Conditions
Keywords
intracoronary stent, drug eluting stent, sirolimus, endothelial progenitor cells
Brief summary
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.
Interventions
DEVICEcoronary stenting
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
Sponsors
OrbusNeich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria * The patient must be ≥18 and ≤ 80 years of age; * Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or objective evidence of myocardial ischemia); * Acceptable candidate for CABG; * The Patient is willing to comply with specified follow-up evaluations; * The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC). Angiographic Inclusion Criteria: * Single de novo or non-stented restenotic lesion in the target vessel; * Patients with two-vessel coronary disease, may have undergone successful treatment (\<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure, cannot be an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty; * Target lesion located in a native coronary artery; * Target lesion (maximum length is 20 mm by visual estimate) covered by a single stent maximum 23 mm length for Combo Stent, and 24 mm in length for TAXUS® Liberté® (stent coverage including at least 3 mm of healthy vessel is recommended). The lesion length should be measured after pre-dilation procedure; * Reference vessel diameter must be ≥2.5 to ≤ 3.5 mm by visual estimate. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected; * Target lesion ≥50% and \<100% stenosed by visual estimate.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES | 9 months post-procedure. |
Secondary
| Measure | Time frame |
|---|---|
| In-stent and in-segment angiographic binary restenosis | 9 months |
| In-stent and in-segment minimum lumen diameter (MLD) | 9 months |
| In-stent, proximal and distal late lumen loss | 9 months |
| Procedure success defined as lesion success without the occurrence of in-hospital MACE | Up to hospital discharge |
| Clinically (ischemia)-driven target lesion revascularization | 30 days, 9 months, 1, 2, 3, 4 and 5 years |
| All-cause and cardiac mortality | 30 days, 9 months, 1, 2, 3, 4, and 5 year |
| Myocardial infarction: Q-wave and non Q-wave, cumulative and individual | 30 days, 9 months, 1, 2, 3, 4, and 5 years |
| Clinically (ischemia)-driven target vessel revascularization | 30 days, 9 months, 1, 2, 3, 4 and 5 years |
| Vascular complications from index procedure | 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 | 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure |
| Change in human anti-murine antibody (HAMA) plasma levels | 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 | Index procedure |
| Lesion success defined as attainment of < 50% residual stenosis using any percutaneous method | Index procedure |
| Neointimal hyperplasia volume and % in-stent volume obstruction as measured by intravascular ultrasound (IVUS) for patients receiving angiographic/IVUS follow-up | 9 months |
| Target lesion failure (TLF) (defined as death, MI and ischemic target lesion revascularization (TLR)) | 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 | Hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure |
Countries
Australia
Outcome results
None listed