Coronary Artery Disease Clinical Trial
— SPIRIT VOfficial title:
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
Verified date | October 2010 |
Source | Abbott Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2700 |
Est. completion date | June 2010 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Salzburger Landeskliniken | Salzburg | |
Belgium | UCL St Luc | Brussels | |
Belgium | ULB Erasmus Hospital | Brussels | |
Belgium | UZ Gent | Gent | |
Belgium | Hopital St Joseph | Gilly | |
Belgium | Clinique St. Luc - Bouge | Namur | |
Canada | 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 | Quebec | |
Canada | Sunnybrook and Women's College | Toronto | |
Canada | University health Network - Toronto Gen Hospital | Toronto | |
China | Fuwai Hospital | Beijing | |
China | Prince of Wales Hospital | Hong Kong | |
China | PYNEH | Hong Kong | |
China | Queen Elizabeth | Hong Kong | |
China | Zhongshan Hospital | Shangai | |
Czech Republic | Univerzity Hospital Hradec Králové | Karlove | |
France | C.H.U. - Hopital Michallon | Grenoble | |
France | CHU Lille - Hôpital Cardiologique | Lille | |
France | NCN - Nouvelle Cliniques Nantaises | Nantes | |
France | Hopital privé Les Fransiscaines | Nimes | |
France | La pitié Salpétrière | Paris | |
France | Polyclinique St Laurent | Rennes | |
France | C.C.N. | Saint Denis | |
Germany | 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 | |
Greece | Onassis Cardiac Center | Athens | |
India | 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 | |
Ireland | Beaumont Hospital | Dublin | |
Ireland | University Hospital Galway | Galway | |
Israel | Hadassah-Hebrew University Medical Center | Jerusalem | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Ichilov Medical Center | Tel-Aviv | |
Italy | 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 | Padova | |
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 | |
Malaysia | Institute Jantung Negara | Kuala Lumpur | |
Malaysia | Sarawak General Hospital | Kuching | |
Netherlands | Medisch Centrum Alkmaar | Alkmaar | |
Netherlands | Catharina ZH Eindhoven | Eindhoven | |
Netherlands | Maasstad Ziekenhuis | Rotterdam | |
New Zealand | Christchurch Hospital | Christchurch | |
Portugal | Hospital Santa Marta | Lisboa | |
Portugal | Hospital Garcia da Orta | Lisbon | |
Portugal | Hospital Santa Cruz | Lisbon | |
Singapore | National University Hospital | Singapore | |
South Africa | Sunninghill Hospital | Johannesburg | |
South Africa | Vergelegen Clinic | Vergelegen | |
Spain | 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 | 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 | Policlinica Gipuzkoa | San Sebastian | |
Spain | Marques de Valdecilla | Santander | |
Spain | Meixoeiro-Medtec | Vigo | |
Sweden | Uppsala Univ. Hospital | Uppsala | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Thailand | Bhumibol Adulyadej Hospital | Bangkok | |
Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
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 | Wessex Cardiac Unit | Southampton |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
Austria, Belgium, Canada, China, Czech Republic, France, Germany, Greece, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . | at 30 days | Yes | |
Secondary | SPIRIT V Registry: Acute Success (Clinical Procedure Success) | Acute | Yes | |
Secondary | SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) | at 30 days, 1 and 2 years | Yes | |
Secondary | SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) | at 30 days, 1 and 2 years | Yes | |
Secondary | SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR | at 30 days, 1 and 2 years | Yes | |
Secondary | SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR | at 30 days, 1 and 2 years | Yes | |
Secondary | 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 | Yes | |
Secondary | SPIRIT V Registry: Acute Success (Clinical Device Success) | Acute | Yes |
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