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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Drug eluting stent implantation stent in the treatment of coronary artery disease
In-stent late loss (LL)
Time frame: at 180 days
In-segment Late Loss
Time frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent Late Loss at 2 years (for a subset of 152 patients)
Time frame: at 2 years (for a subset of 152 patients)
Proximal and distal Late Loss
Time frame: 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
Time frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent and in-segment percent Diameter Stenosis (% DS)
Time frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
In-stent percent Volume Obstruction (% VO)
Time frame: at 180 days and at 2 years for a subset of 152 patients
Plaque behind the stent( by IVUS)
Time frame: at 180 days and at 2 years for a subset of 152 patients
Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate
Time frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Ischemia Driven Target Vessel Failure (ID-TVF)
Time frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
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Wilheminenspital der Stadt Wien
Vienna, Austria
A.Z. Middelheim
Antwerp, Belgium
C.H.R. La Citadelle
Liège, Belgium
C.H.U. de Liège Sart Tilman
Liège, Belgium
Aalborg Sygehus Syd
Aalborg, Denmark
Århus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Hôpital Cochin
Paris, France
Clinique Saint Hilaire
Rouen, France
Clinique Pasteur
Toulouse, France
...and 22 more locations
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years
Persisting incomplete stent apposition, late-acquired incomplete stent apposition
Time frame: at 180 days and at 2 years for a subset of 152 patients
Aneurysm, thrombosis and persisting dissection
Time frame: at 180 days (all patients) and at 2 years (for a subset of 152 patients)
Acute success(device, procedure and clinical)
Time frame: Acute