SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System (SPIRIT II)
Coronary Disease, Coronary Artery Disease, Coronary Restenosis
About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
Eligibility 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
Sites / Locations
- Wilheminenspital der Stadt Wien
- A.Z. Middelheim
- C.H.R. La Citadelle
- C.H.U. de Liège Sart Tilman
- Aalborg Sygehus Syd
- Århus University Hospital
- Rigshospitalet
- Hôpital Cochin
- Clinique Saint Hilaire
- Clinique Pasteur
- Hôpital de Rangueil CHU
- Clinique Saint Gatien
- Herzzentrum Bad Oeynhausen
- Segeberger Kliniken GmbH
- Amper Kliniken AG Klinikum Dachau
- Herz- und Gefäßzentrum Hamburg
- Klinikum Kassel
- Max Devki Devi Heart & Vascular Institute
- Azienda Ospedaliera Santa Maria Nuova
- Academisch Medisch Centrum
- Amphia Hospital
- St. Antonius Ziekenhuis Nieuwegein
- Erasmus Medical Center
- Isala Klinieken - Locatie Weezenlanden
- The Mercy Hospital
- Auckland City Hospital
- National Institute of Cardiology in Warsaw
- Vergelegen Mediclinic
- Hospital Clinico San Carlos
- University Hospital Gregorio Maranon
- Kantonsspital Basel
- R.V. Hôpital Cantonal Universitaire de Geneve
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
XIENCE V® Everolimus Eluting Coronary Stent System
TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent