Clinical trial NCT00402272: SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: drug eluting stents
stents
Angioplasty
coronary artery disease
total coronary occlusion
coronary artery restenosis
stent thrombosis
vascular disease
myocardial ischemia
coronary artery stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
timeFrame: at 30 days
Secondary outcomes:
measure: SPIRIT V Registry: Acute Success (Clinical Procedure Success)
timeFrame: Acute
measure: SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
timeFrame: at 30 days, 1 and 2 years
measure: SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
timeFrame: at 30 days, 1 and 2 years
measure: SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
timeFrame: at 30 days, 1 and 2 years
measure: SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
timeFrame: at 30 days, 1 and 2 years
measure: SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
timeFrame: at 30 days, 1 and 2 years
measure: SPIRIT V Registry: Acute Success (Clinical Device Success)
timeFrame: Acute
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Brussels
country: Belgium
facility: UCL St Luc
city: Brussels
country: Belgium
facility: ULB Erasmus Hospital
city: Gent
country: Belgium
facility: UZ Gent
city: Gilly
country: Belgium
facility: Hopital St Joseph
city: Namur
country: Belgium
facility: Clinique St. Luc - Bouge
city: Calgary
country: Canada
facility: Foothills Medical Center
city: Montreal
country: Canada
facility: CHUM Hotel Dieu Hospital
city: Montreal
country: Canada
facility: Montreal Heart Institute
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Quebec
country: Canada
facility: Hôpital Laval
city: Toronto
country: Canada
facility: Sunnybrook and Women's College
city: Toronto
country: Canada
facility: University health Network - Toronto Gen Hospital
city: Beijing
country: China
facility: Fuwai Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Hong Kong
country: China
facility: PYNEH
city: Hong Kong
country: China
facility: Queen Elizabeth
city: Shangai
country: China
facility: Zhongshan Hospital
city: Karlove
country: Czech Republic
facility: Univerzity Hospital Hradec Králové
city: Grenoble
country: France
facility: C.H.U. - Hopital Michallon
city: Lille
country: France
facility: CHU Lille - Hôpital Cardiologique
city: Nantes
country: France
facility: NCN - Nouvelle Cliniques Nantaises
city: Nimes
country: France
facility: Hopital privé Les Fransiscaines
city: Paris
country: France
facility: La pitié Salpétrière
city: Rennes
country: France
facility: Polyclinique St Laurent
city: Saint Denis
country: France
facility: C.C.N.
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
city: Bernau
country: Germany
facility: Herzzentrum
city: Heidelberg
country: Germany
facility: Universitätsklinikum
city: Neuss
country: Germany
facility: Lukas Krankenhaus Neuss
city: Siegburg
country: Germany
facility: Herzzentrum Siegburg GmbH
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
city: Athens
country: Greece
facility: Onassis Cardiac Center
city: Ahmedabad
country: India
facility: Krishna Heart Institute
city: Chennai
country: India
facility: Apollo Hospital
city: Chennai
country: India
facility: Institute of Cardiovascular Disease M.M.M.
city: Delhi
country: India
facility: All India Institute of Medical Science - AIIMS
city: Delhi
country: India
facility: Fortis Hospital
city: Kolkata
country: India
facility: B M Birla
city: New Delhi
country: India
facility: Kailash Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Ichilov Medical Center
city: Arezzo
country: Italy
facility: Azienda USL 8
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Riuniti
city: Brescia
country: Italy
facility: Emodinamica Azienda Spedali Civili
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu
city: Mestre
country: Italy
facility: Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1
city: Mirano
country: Italy
facility: Ospedale Civile
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Roma
country: Italy
facility: Policlinico A. Gemelli
city: Salerno
country: Italy
facility: Azienda Ospedaliera S. Gdi Dio Salerno
city: Kuala Lumpur
country: Malaysia
facility: Institute Jantung Negara
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Eindhoven
country: Netherlands
facility: Catharina ZH Eindhoven
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Lisboa
country: Portugal
facility: Hospital Santa Marta
city: Lisbon
country: Portugal
facility: Hospital Garcia da Orta
city: Lisbon
country: Portugal
facility: Hospital Santa Cruz
city: Singapore
country: Singapore
facility: National University Hospital
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
city: Vergelegen
country: South Africa
facility: Vergelegen Clinic
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvigte
city: Barcelona
country: Spain
facility: Trias Y Pujol
city: Barcelona
country: Spain
facility: Valle Hebron
city: Cadiz
country: Spain
facility: Puerta del Mar
city: Madrid
country: Spain
facility: Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: La Paz
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: San Sebastian
country: Spain
facility: Policlinica Gipuzkoa
city: Santander
country: Spain
facility: Marques de Valdecilla
city: Vigo
country: Spain
facility: Meixoeiro-Medtec
city: Uppsala
country: Sweden
facility: Uppsala Univ. Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County, Brighton
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Southampton
country: United Kingdom
facility: Wessex Cardiac Unit
Study officials:
affiliation: The Heart Center, Siegburg, Germany
name: Eberhard Grube, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fortis Hospital, New Delhi, India
name: Upendra Kaul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.
citation: Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.