Coronary Artery Disease, Coronary Disease, Coronary Restenosis
Conditions
Keywords
drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
Brief summary
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System. TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.
Detailed description
The SPIRIT II trial was a randomized, single blind, active control, multi-center clinical evaluation. Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies. In this study, 300 subjects (3:1 randomization XIENCE V® EECSS: TAXUS™ PECSS were enrolled at 31 sites outside the United States. The primary endpoint was in-stent late loss at 6 months. Secondary endpoints included clinical outcomes at months 1, 6, and 9 months and 1, 2, 3, 4 and 5 years; angiographic results at 6 months and 2 years; and IVUS results at 6 months and 2 years. Follow-up through 3 years is currently available.
Interventions
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Drug eluting stent implantation stent in the treatment of coronary artery disease
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* De novo Target lesion(s) must be located in a native epicardial vessel with diameter between 2.25 mm and 4.25 mm by visual estimate * The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of \>= 50% and \< 100% with a TIMI flow of \>= 1 * Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done \>= 90 days prior to the index procedure or if planned to be done \> 9 months after the index procedure
Exclusion criteria
* De novo target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) \< 9 months prior to index procedure * Target lesion(s) restenotic from previous intervention * Target lesion(s) located in a major epicardial vessel that has been previously treated with brachytherapy * Target vessel(s) contains visible thrombus * Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy) * Patient has additional clinically significant lesion(s) (\> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late loss (LL) | at 180 days |
Secondary
| Measure | Time frame |
|---|---|
| In-stent Late Loss at 2 years (for a subset of 152 patients) | at 2 years (for a subset of 152 patients) |
| Proximal and distal Late Loss | at 180 days (all patients) and at 2 years (for a subset of 152 patients) |
| In-stent and in-segment Angiographic Binary Restenosis (ABR) rate | at 180 days (all patients) and at 2 years (for a subset of 152 patients) |
| In-stent and in-segment percent Diameter Stenosis (% DS) | at 180 days (all patients) and at 2 years (for a subset of 152 patients) |
| In-stent percent Volume Obstruction (% VO) | at 180 days and at 2 years for a subset of 152 patients |
| Plaque behind the stent( by IVUS) | at 180 days and at 2 years for a subset of 152 patients |
| In-segment Late Loss | at 180 days (all patients) and at 2 years (for a subset of 152 patients) |
| Ischemia Driven Target Vessel Failure (ID-TVF) | at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years |
| Ischemia Driven Target Lesion Revascularization (ID-TLR) | at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years |
| Persisting incomplete stent apposition, late-acquired incomplete stent apposition | at 180 days and at 2 years for a subset of 152 patients |
| Aneurysm, thrombosis and persisting dissection | at 180 days (all patients) and at 2 years (for a subset of 152 patients) |
| Acute success(device, procedure and clinical) | Acute |
| Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate | at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years |
Countries
Austria, Belgium, Denmark, France, Germany, India, Italy, Netherlands, New Zealand, Poland, South Africa, Spain, Switzerland
Outcome results
None listed