XIENCE V: SPIRIT WOMEN
- Conditions
- Coronary Artery StenosisCoronary Artery RestenosisVascular DiseaseTotal Coronary OcclusionCoronary ArteriosclerosisCoronary Artery DiseaseMyocardial IschemiaStent Thrombosis
- Interventions
- Device: XIENCE V®/ XIENCE PRIME™
- Registration Number
- NCT00496938
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
- Detailed Description
SPIRIT Women Single-Arm Study: A prospective, open label, single arm, multi-center study evaluating performance of the XIENCE V® and XIENCE PRIME™ EECSS in the treatment of female patients with coronary artery lesions, per its Instructions for Use (IFU).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1600
- Patient must be female.
- 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.
Angiographic Inclusion Criteria:
- 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.
General
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 XIENCE V®/ XIENCE PRIME™ Observational cohort using an all-comers design
- Primary Outcome Measures
Name Time Method Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 1 year
- Secondary Outcome Measures
Name Time Method Acute Success (Clinical Device Success and Clinical Procedure Success) Acute Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. at 2 Years Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). at 2 Years Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. at 2 years Adjudicated Stent Thrombosis (Definite, Probable, Possible) at 2 Years Adjudicated revascularization (TLR/TVR/all revascularizations) at 2 years Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). at 2 Years
Trial Locations
- Locations (94)
AMC
🇳🇱Amsterdam, Netherlands
Azienda Ospedaliera Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Centro Cardiologico Monzino
🇮🇹Milan, Italy
Bakulev Scientific Center for Cardiovascular Surgery
🇷🇺Moscow, Russian Federation
Escorts Heart Institute & Research Centre
🇮🇳New Delhi, India
Instituto Cardiovascular de Buenos Aires-ICBA
🇦🇷Buenos Aires, Argentina
Hosital Italiano de Buenos Aires - Cardiologia
🇦🇷Buenos Aires, Argentina
The Northern Hospital
🇦🇺Epping, Australia
Liverpool Hospital
🇦🇺New South Wales, Australia
Landesklinikum St. Pölten
🇦🇹St. Poelten, Austria
Klinikum Kreuzschwestern Wels GmbH
🇦🇹Wels, Austria
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
🇦🇹Wien, Austria
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
Hospital Madre Teresa
🇧🇷Belo Horizonte, Brazil
CHU Charleroi
🇧🇪Charleroi, Belgium
Heilig Hart Ziekenhuis Roeselare
🇧🇪Roeselare, Belgium
Hospital Moinhos de Ventos-Centro de Cardiologia
🇧🇷Porto Alegre, Brazil
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
🇧🇷Sao Paulo, Brazil
INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP
🇧🇷Sao Paulo, Brazil
Queen Mary Hospital
🇨🇳Hong Kong, Hong Kong, China
Tuen Mun Hospital
🇨🇳Hong Kong, Hong Kong, China
Queen Elizabeth Hospital
🇬🇧London, United Kingdom
Guangzhou Army General Hospital
🇨🇳Guangzhou, China
China People Liberation Army (PLA) General Hospital
🇨🇳Beijing, China
Fu Wai Hospital
🇨🇳Beijing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Shanghai Renji Hospital (East)
🇨🇳Shanghai, China
United Christian Hospital
🇨🇳Hong Kong, China
Hôpital Henri Duffaut
🇫🇷Avignon Cedex 9, France
Rigshospitalet
🇩🇰Copenhagen, Denmark
Clinique Saint Augustin
🇫🇷Bordeaux, France
Hôpital de la Cavale Blanche
🇫🇷Brest Cedex, France
Hôpital Charles Nicolle
🇫🇷Rouen, 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 Cedex, 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
Klinikum Ludwigshafen
🇩🇪Ludwigshafen, Germany
Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik
🇩🇪Mainz, Germany
Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie
🇩🇪Hannover, Germany
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Onassis Cardiac Surgery Hospital
🇬🇷Athens, Greece
Kliniken Villingen
🇩🇪Villingen-Schwenningen, Germany
Semmelweis University, Department of Cardiovascular Surgery
🇭🇺Budapest, Hungary
University of Pécs/Medical School/Heart Institute
🇭🇺Pécs, Hungary
Cardiology Clinic of Papageorgiou Hospital
🇬🇷Thessaloniki, Greece
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
Wolfson Medical Center
🇮🇱Holon, Israel
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
🇮🇹Milano, Italy
Ospedale A. Manzoni
🇮🇹Lecco, Italy
Hesperia Hospital
🇮🇹Modena, Italy
Ospedale Cisanello
🇮🇹Pisa, Italy
A.O Di Perugia, Ospedale Silvestrini
🇮🇹Perugia, Italy
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
🇮🇹Modena, Italy
L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli
🇮🇹Palermo, 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
Haukeland university hospital
🇳🇴Bergen, Norway
Het Onze Lieve Vrouwe Gasthuis (OLVG)
🇳🇱Amsterdam, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Feiringklinikken AS
🇳🇴Feiring, Norway
Hospital Santa Maria
🇵🇹Lisboa, Portugal
Polsko Amerykanskie-Kliniki Serca American Heart
🇵🇱Ustroń, Poland
Institute of Cardiology
🇵🇱Warsaw, Poland
Hospitalar Santa Marta
🇵🇹Lisboa, Portugal
Hospital São João
🇵🇹Porto, Portugal
Bloemfontein Medi-Clinic
🇿🇦Bloemfontein, South Africa
Hospital General de Alicante
🇪🇸Alicante, Spain
Unitas Hospital
🇿🇦Pretoria, South Africa
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
Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Hôpitaux Universitaires de Genève
🇨🇭Geneve, Switzerland
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