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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1600 participants
INTERVENTIONAL
2007-07-31
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
XIENCE V: SPIRIT WOMEN Sub-study
NCT01182428
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
NCT01171820
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
NCT00180479
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
NCT00402272
XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
NCT00731237
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Observational cohort using an all-comers design
XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 CIP-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
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie-Claude Morice
Role: PRINCIPAL_INVESTIGATOR
Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Stephan Windecker
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bern, Bern, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, Buenos Aires, Argentina
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, , Argentina
The Northern Hospital
Epping, , Australia
Liverpool Hospital
New South Wales, , Australia
Landesklinikum St. Pölten
Sankt Pölten, , Austria
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Vienna, , Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, , Austria
Universitair Ziekenhuis Brussel
Brussels, , Belgium
CHU Charleroi
Charleroi, , Belgium
Heilig Hart Ziekenhuis Roeselare
Roeselare, , Belgium
Hospital Madre Teresa
Belo Horizonte, , Brazil
Hospital Moinhos de Ventos-Centro de Cardiologia
Porto Alegre, , Brazil
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
São Paulo, , Brazil
INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP
São Paulo, , Brazil
Queen Elizabeth Hospital
Hong Kong, Hong Kong, China
Queen Mary Hospital
Hong Kong, Hong Kong, China
Tuen Mun Hospital
Hong Kong, Hong Kong, China
Fu Wai Hospital
Beijing, , China
China People Liberation Army (PLA) General Hospital
Beijing, , China
Guangzhou Army General Hospital
Guangzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
United Christian Hospital
Hong Kong, , China
Shanghai Renji Hospital (East)
Shanghai, , China
Rigshospitalet
Copenhagen, , Denmark
Hôpital Henri Duffaut
Avignon, , France
Clinique Saint Augustin
Bordeaux, , France
Hôpital de la Cavale Blanche
Brest, , France
Hôpital du Bocage - CHU
Dijon, , France
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
Massy, , France
Hôpital Arnaud de Villeneuve - CHU
Montpellier, , France
Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU
Rennes, , France
Hôpital Charles Nicolle
Rouen, , France
Kardiologische Klinik Herz- und Diabeteszentrum
Bad Oeynhausen, , Germany
Segebergerkliniken
Bad Segeberg, , Germany
Klinikum Coburg GmbH
Coburg, , Germany
Amper Kliniken-Kreisklinik
Dachau, , Germany
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
Dresden, , Germany
Universitäres Herzzentrum, Medizinische Klinik III
Hamburg, , Germany
Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie
Hanover, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik
Mainz, , Germany
Krankenhaus der Barmherzigen Brüder
Trier, , Germany
Kliniken Villingen
Villingen-Schwenningen, , Germany
Onassis Cardiac Surgery Hospital
Athens, , Greece
Cardiology Clinic of Papageorgiou Hospital
Thessaloniki, , Greece
Semmelweis University, Department of Cardiovascular Surgery
Budapest, , Hungary
University of Pécs/Medical School/Heart Institute
Pécs, , Hungary
Apollo Hospital
Hyderabaad, Andhar Pradesh, India
CARE Hospital
Hyderabaad, Andhra Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, , India
Max Devki Devi Heart & Vascular Insititute, Department of Cardiology
New Delhi, , India
Escorts Heart Institute & Research Centre
New Delhi, , India
Wolfson Medical Center
Holon, , Israel
Ospedale A. Manzoni
Lecco, , Italy
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
Hesperia Hospital
Modena, , Italy
L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli
Palermo, , Italy
A.O Di Perugia, Ospedale Silvestrini
Perugia, , Italy
Ospedale Cisanello
Pisa, , Italy
Azienda Ospedaliera Santa Maria Nuova
Reggio Emilia, , Italy
A.O. Universitaria Tor Vergata, Cardiologia
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Instituto Policlinico S. Donato
San Donato, , Italy
Latvian Center of Cardiology, P. Stradina University Hospital
Riga, , Latvia
University Malay Medical Center
Kuala Lumpur, Lembah Pantai, Malaysia
Het Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, , Netherlands
AMC
Amsterdam, , Netherlands
Amphia Hospital
Breda, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Haukeland university hospital
Bergen, , Norway
Feiringklinikken AS
Feiring, , Norway
Polsko Amerykanskie-Kliniki Serca American Heart
Ustroń, , Poland
Institute of Cardiology
Warsaw, , Poland
Hospital Santa Maria
Lisbon, , Portugal
Hospitalar Santa Marta
Lisbon, , Portugal
Hospital São João
Porto, , Portugal
Bakulev Scientific Center for Cardiovascular Surgery
Moscow, , Russia
Bloemfontein Medi-Clinic
Bloemfontein, , South Africa
Unitas Hospital
Pretoria, , South Africa
Hospital General de Alicante
Alicante, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Clinico San Carlos, Hemodynamics Department
Madrid, , Spain
H. Miguel Servet. Zaragoza, Cardiology Service
Zaragoza, , Spain
Inselspital Bern, Kardiologie
Bern, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
Queen Elizabeth Hospital
London, , United Kingdom
Freeman Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Centro Medico de Caracas
Caracas, , Venezuela
Clinica Santa Sofia
Caracas, , Venezuela
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
07-377
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.