SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
- Conditions
- Coronary DiseaseCoronary Artery DiseaseCoronary Restenosis
- Interventions
- Device: XIENCE V® Everolimus Eluting Coronary Stent
- Registration Number
- NCT00402272
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.
- Detailed Description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2700
- at least 18 years
- 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
Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 XIENCE V® Everolimus Eluting Coronary Stent XIENCE V® Everolimus Eluting Coronary Stent System
- Primary Outcome Measures
Name Time Method SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . at 30 days
- Secondary Outcome Measures
Name Time Method SPIRIT V Registry: Acute Success (Clinical Procedure Success) Acute SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) at 30 days, 1 and 2 years SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) at 30 days, 1 and 2 years SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR at 30 days, 1 and 2 years SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR at 30 days, 1 and 2 years SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR) at 30 days, 1 and 2 years SPIRIT V Registry: Acute Success (Clinical Device Success) Acute
Trial Locations
- Locations (93)
Herzzentrum Siegburg GmbH
🇩🇪Siegburg, Germany
Krishna Heart Institute
🇮🇳Ahmedabad, India
Meixoeiro-Medtec
🇪🇸Vigo, Spain
C.H.U. - Hopital Michallon
🇫🇷Grenoble, France
ULB Erasmus Hospital
🇧🇪Brussels, Belgium
UZ Gent
🇧🇪Gent, Belgium
NCN - Nouvelle Cliniques Nantaises
🇫🇷Nantes, France
Montreal Heart Institute
🇨🇦Montreal, Canada
La pitié Salpétrière
🇫🇷Paris, France
Sunnybrook and Women's College
🇨🇦Toronto, Canada
Prince of Wales Hospital
🇨🇳Hong Kong, China
Apollo Hospital
🇮🇳Chennai, India
Polyclinique St Laurent
🇫🇷Rennes, France
CHUM Hotel Dieu Hospital
🇨🇦Montreal, Canada
Kerckhoff Klinik GmbH
🇩🇪Bad Nauheim, Germany
Foothills Medical Center
🇨🇦Calgary, Canada
Queen Elizabeth
🇨🇳Hong Kong, China
Policlinica Gipuzkoa
🇪🇸San Sebastian, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hopital St Joseph
🇧🇪Gilly, Belgium
Uppsala Univ. Hospital
🇸🇪Uppsala, Sweden
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
University of Ottawa Heart Institute
🇨🇦Ottawa, Canada
Clinique St. Luc - Bouge
🇧🇪Namur, Belgium
Marques de Valdecilla
🇪🇸Santander, Spain
Glenfield Hospital
🇬🇧Leicester, United Kingdom
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Wessex Cardiac Unit
🇬🇧Southampton, United Kingdom
Bhumibol Adulyadej Hospital
🇹🇭Bangkok, Thailand
Royal Sussex County, Brighton
🇬🇧Brighton, United Kingdom
Emodinamica Azienda Spedali Civili
🇮🇹Brescia, Italy
Ospedale Civile
🇮🇹Mirano, Italy
Zhongshan Hospital
🇨🇳Shangai, China
Policlinico A. Gemelli
🇮🇹Roma, Italy
Puerta del Mar
🇪🇸Cadiz, Spain
Salzburger Landeskliniken
🇦🇹Salzburg, Austria
Fuwai Hospital
🇨🇳Beijing, China
PYNEH
🇨🇳Hong Kong, China
University health Network - Toronto Gen Hospital
🇨🇦Toronto, Canada
Hôpital Laval
🇨🇦Quebec, Canada
Hopital privé Les Fransiscaines
🇫🇷Nimes, France
CHU Lille - Hôpital Cardiologique
🇫🇷Lille, France
Lukas Krankenhaus Neuss
🇩🇪Neuss, Germany
Universitätsklinikum
🇩🇪Heidelberg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
C.C.N.
🇫🇷Saint Denis, France
Herzzentrum
🇩🇪Bernau, Germany
Helios Klinikum Wuppertal
🇩🇪Wuppertal, Germany
Onassis Cardiac Center
🇬🇷Athens, Greece
All India Institute of Medical Science - AIIMS
🇮🇳Delhi, India
Institute of Cardiovascular Disease M.M.M.
🇮🇳Chennai, India
University Hospital Galway
🇮🇪Galway, Ireland
Hadassah-Hebrew University Medical Center
🇮🇱Jerusalem, Israel
B M Birla
🇮🇳Kolkata, India
Fortis Hospital
🇮🇳Delhi, India
Kailash Hospital
🇮🇳New Delhi, India
Azienda Ospedaliera G. Brotzu
🇮🇹Cagliari, Italy
Beaumont Hospital
🇮🇪Dublin, Ireland
Azienda USL 8
🇮🇹Arezzo, Italy
Ichilov Medical Center
🇮🇱Tel-Aviv, Israel
Azienda Ospedaliera Riuniti
🇮🇹Bergamo, Italy
Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
🇮🇹Mestre, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Ospedale San Filippo Neri
🇮🇹Roma, Italy
Azienda Ospedaliera S. Gdi Dio Salerno
🇮🇹Salerno, Italy
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Sarawak General Hospital
🇲🇾Kuching, Malaysia
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Hospital del Mar
🇪🇸Barcelona, Spain
Vergelegen Clinic
🇿🇦Vergelegen, South Africa
Sunninghill Hospital
🇿🇦Johannesburg, South Africa
Hospital Santa Marta
🇵🇹Lisboa, Portugal
Hospital Universitari de Bellvigte
🇪🇸Barcelona, Spain
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Trias Y Pujol
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Clinico San Carlos
🇪🇸Madrid, Spain
Valle Hebron
🇪🇸Barcelona, Spain
La Paz
🇪🇸Madrid, Spain
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Hospital Santa Cruz
🇵🇹Lisbon, Portugal
National University Hospital
🇸🇬Singapore, Singapore
UCL St Luc
🇧🇪Brussels, Belgium
Univerzity Hospital Hradec Králové
🇨🇿Karlove, Czech Republic
Institute Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Catharina ZH Eindhoven
🇳🇱Eindhoven, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, Netherlands
Hospital Garcia da Orta
🇵🇹Lisbon, Portugal
Ruby Hall Clinic
🇮🇳Pune, India