Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
455 participants
INTERVENTIONAL
2008-09-30
2011-07-31
Brief Summary
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Detailed Description
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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 Women study after 2 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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XIENCE V® / XIENCE PRIME™
XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
CYPHER SELECT
CYPHER SELECT
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
Interventions
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XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
CYPHER SELECT
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
Eligibility Criteria
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Inclusion Criteria
* Patient must be at least 18 years of age.
* Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or 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.
* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
* Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
* Patient must agree to undergo all protocol-required follow-up examinations.
* Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
* Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
* Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
* Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
* Target lesion greater than or equal to 28 mm in length by visual estimate.
Exclusion Criteria
* Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
* Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
* Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
* Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)
18 Years
FEMALE
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Claude Morice
Role: PRINCIPAL_INVESTIGATOR
Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Stephan Windecker
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Bern, Switzerland
Locations
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Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, Buenos Aires, Argentina
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, , Argentina
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Vienna, , Austria
Heilig Hart Ziekenhuis Roeselare
Roeselare, , Belgium
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
São Paulo, , Brazil
Rigshospitalet
Copenhagen, , Denmark
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
Massy, , France
Kardiologische Klinik Herz- und Diabeteszentrum
Bad Oeynhausen, , Germany
Segebergerkliniken
Bad Segeberg, , Germany
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
Dresden, , Germany
Semmelweis University, Department of Cardiovascular Surgery
Budapest, , Hungary
Centro Cardiologico Monzino
Milan, , Italy
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
Milan, , Italy
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
Modena, , Italy
Ospedale Cisanello
Pisa, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Latvian Center of Cardiology, P. Stradina University Hospital
Riga, , Latvia
AMC
Amsterdam, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Haukeland university hospital
Bergen, , Norway
Institute of Cardiology
Warsaw, , Poland
Hospital General de Alicante
Alicante, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Inselspital Bern, Kardiologie
Bern, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
Countries
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References
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Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.
Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.
Other Identifiers
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07-377 sub-study
Identifier Type: -
Identifier Source: org_study_id