SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
NCT ID: NCT00402272
Last Updated: 2010-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2700 participants
INTERVENTIONAL
2006-11-30
2010-06-30
Brief Summary
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Detailed Description
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The SPIRIT V Registry is a prospective, single arm, multi-center registry evaluating performance of the XIENCE V® EECSS in real-world use, per its Instruction For Use (IFU). 2,700 patients will be enrolled in the SPIRIT V Registry.
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.
Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
XIENCE V® Everolimus Eluting Coronary Stent System
XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Interventions
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XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
* evidence of myocardial ischemia
* acceptable candidate for coronary artery bypass graft (CABG) surgery
* undergo all CIP-required follow-up examinations
* artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC
* target lesions must be de novo lesions
* target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
* target lesion ≤ 28 mm in length by visual estimate
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Abbott Vascular
Principal Investigators
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Eberhard Grube, MD
Role: PRINCIPAL_INVESTIGATOR
The Heart Center, Siegburg, Germany
Upendra Kaul, MD
Role: PRINCIPAL_INVESTIGATOR
Fortis Hospital, New Delhi, India
Locations
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Salzburger Landeskliniken
Salzburg, , Austria
UCL St Luc
Brussels, , Belgium
ULB Erasmus Hospital
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Hopital St Joseph
Gilly, , Belgium
Clinique St. Luc - Bouge
Namur, , Belgium
Foothills Medical Center
Calgary, , Canada
CHUM Hotel Dieu Hospital
Montreal, , Canada
Montreal Heart Institute
Montreal, , Canada
University of Ottawa Heart Institute
Ottawa, , Canada
Hôpital Laval
Québec, , Canada
Sunnybrook and Women's College
Toronto, , Canada
University health Network - Toronto Gen Hospital
Toronto, , Canada
Fuwai Hospital
Beijing, , China
Prince of Wales Hospital
Hong Kong, , China
PYNEH
Hong Kong, , China
Queen Elizabeth
Hong Kong, , China
Zhongshan Hospital
Shanghai, , China
Univerzity Hospital Hradec Králové
Karlove, , Czechia
C.H.U. - Hopital Michallon
Grenoble, , France
CHU Lille - Hôpital Cardiologique
Lille, , France
NCN - Nouvelle Cliniques Nantaises
Nantes, , France
Hopital privé Les Fransiscaines
Nîmes, , France
La pitié Salpétrière
Paris, , France
Polyclinique St Laurent
Rennes, , France
C.C.N.
Saint-Denis, , France
Kerckhoff Klinik GmbH
Bad Nauheim, , Germany
Herzzentrum
Bernau, , Germany
Universitätsklinikum
Heidelberg, , Germany
Lukas Krankenhaus Neuss
Neuss, , Germany
Herzzentrum Siegburg GmbH
Siegburg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Onassis Cardiac Center
Athens, , Greece
Krishna Heart Institute
Ahmedabad, , India
Apollo Hospital
Chennai, , India
Institute of Cardiovascular Disease M.M.M.
Chennai, , India
All India Institute of Medical Science - AIIMS
Delhi, , India
Fortis Hospital
Delhi, , India
B M Birla
Kolkata, , India
Kailash Hospital
New Delhi, , India
Ruby Hall Clinic
Pune, , India
Beaumont Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Hadassah-Hebrew University Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Ichilov Medical Center
Tel Aviv, , Israel
Azienda USL 8
Arezzo, , Italy
Azienda Ospedaliera Riuniti
Bergamo, , Italy
Emodinamica Azienda Spedali Civili
Brescia, , Italy
Azienda Ospedaliera G. Brotzu
Cagliari, , Italy
Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
Mestre, , Italy
Ospedale Civile
Mirano, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Ospedale San Filippo Neri
Roma, , Italy
Policlinico A. Gemelli
Roma, , Italy
Azienda Ospedaliera S. Gdi Dio Salerno
Salerno, , Italy
Institute Jantung Negara
Kuala Lumpur, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Catharina ZH Eindhoven
Eindhoven, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Christchurch Hospital
Christchurch, , New Zealand
Hospital Garcia da Orta
Lisbon, , Portugal
Hospital Santa Cruz
Lisbon, , Portugal
Hospital Santa Marta
Lisbon, , Portugal
National University Hospital
Singapore, , Singapore
Sunninghill Hospital
Johannesburg, , South Africa
Vergelegen Clinic
Vergelegen, , South Africa
Hospital del Mar
Barcelona, , Spain
Hospital Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitari de Bellvigte
Barcelona, , Spain
Trias Y Pujol
Barcelona, , Spain
Valle Hebron
Barcelona, , Spain
Puerta del Mar
Cadiz, , Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, , Spain
Clinico San Carlos
Madrid, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
La Paz
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Son Dureta
Palma de Mallorca, , Spain
Marques de Valdecilla
Santander, , Spain
Meixoeiro-Medtec
Vigo, , Spain
Uppsala Univ. Hospital
Uppsala, , Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Bhumibol Adulyadej Hospital
Bangkok, , Thailand
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Wessex Cardiac Unit
Southampton, Southampton, United Kingdom
Royal Sussex County, Brighton
Brighton, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
King's College Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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References
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Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.
Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.
Other Identifiers
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05-369
Identifier Type: -
Identifier Source: org_study_id