SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 XIENCE V® Everolimus Eluting Coronary Stent System |
Device: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Names:
|
| Active Comparator: 2 TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent |
Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
Other Names:
|
Outcome Measures
Primary Outcome Measures
- In-stent late loss (LL) [at 180 days]
Secondary Outcome Measures
- In-segment Late Loss [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) [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]
- Ischemia Driven Major Adverse Cardiac Event (ID-MACE) rate [at 30, 180 and 270 days, 1, 2, 3, 4 and 5 years]
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wilheminenspital der Stadt Wien | Vienna | Austria | 1160 | |
| 2 | A.Z. Middelheim | Antwerpen | Belgium | 2020 | |
| 3 | C.H.R. La Citadelle | Liège | Belgium | 4000 | |
| 4 | C.H.U. de Liège Sart Tilman | Liège | Belgium | 4000 | |
| 5 | Aalborg Sygehus Syd | Aalborg | Denmark | ||
| 6 | Århus University Hospital | Aarhus | Denmark | ||
| 7 | Rigshospitalet | Copenhagen | Denmark | ||
| 8 | Hôpital Cochin | Paris | France | ||
| 9 | Clinique Saint Hilaire | Rouen | France | ||
| 10 | Clinique Pasteur | Toulouse | France | ||
| 11 | Hôpital de Rangueil CHU | Toulouse | France | ||
| 12 | Clinique Saint Gatien | Tours | France | ||
| 13 | Herzzentrum Bad Oeynhausen | Bad Oeynhausen | Germany | 32545 | |
| 14 | Segeberger Kliniken GmbH | Bad Segeberg | Germany | 23795 | |
| 15 | Amper Kliniken AG Klinikum Dachau | Dachau | Germany | ||
| 16 | Herz- und Gefäßzentrum Hamburg | Hamburg | Germany | ||
| 17 | Klinikum Kassel | Kassel | Germany | ||
| 18 | Max Devki Devi Heart & Vascular Institute | New Delhi | India | 110017 | |
| 19 | Azienda Ospedaliera Santa Maria Nuova | Reggio Emilia | Italy | ||
| 20 | Academisch Medisch Centrum | Amsterdam | Netherlands | 1105 AZ | |
| 21 | Amphia Hospital | Breda | Netherlands | ||
| 22 | St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | Netherlands | ||
| 23 | Erasmus Medical Center | Rotterdam | Netherlands | ||
| 24 | Isala Klinieken - Locatie Weezenlanden | Zwolle | Netherlands | ||
| 25 | The Mercy Hospital | Auckland | Epsom | New Zealand | |
| 26 | Auckland City Hospital | Auckland | Grafton | New Zealand | |
| 27 | National Institute of Cardiology in Warsaw | Warsaw | Poland | ||
| 28 | Vergelegen Mediclinic | Cape Town | South Africa | ||
| 29 | Hospital Clinico San Carlos | Madrid | Spain | ||
| 30 | University Hospital Gregorio Maranon | Madrid | Spain | ||
| 31 | Kantonsspital Basel | Basel | Switzerland | ||
| 32 | R.V. Hôpital Cantonal Universitaire de Geneve | Geneva | Switzerland |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Patrick Serruys, Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
Study Documents (Full-Text)
None provided.More Information
Publications
- 03-364