Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00402272
Registration number
NCT00402272
Ethics application status
Date submitted
17/11/2006
Date registered
22/11/2006
Date last updated
14/10/2010
Titles & IDs
Public title
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
05-369
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SPIRIT V
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Coronary Disease
0
0
Query!
Coronary Artery Disease
0
0
Query!
Coronary Restenosis
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - XIENCE V® Everolimus Eluting Coronary Stent
Experimental: 1 - XIENCE V® Everolimus Eluting Coronary Stent System
Treatment: Devices: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
at 30 days
Query!
Secondary outcome [1]
0
0
SPIRIT V Registry: Acute Success (Clinical Procedure Success)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Acute
Query!
Secondary outcome [2]
0
0
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
at 30 days, 1 and 2 years
Query!
Secondary outcome [3]
0
0
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
at 30 days, 1 and 2 years
Query!
Secondary outcome [4]
0
0
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
at 30 days, 1 and 2 years
Query!
Secondary outcome [5]
0
0
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
at 30 days, 1 and 2 years
Query!
Secondary outcome [6]
0
0
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
at 30 days, 1 and 2 years
Query!
Secondary outcome [7]
0
0
SPIRIT V Registry: Acute Success (Clinical Device Success)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Acute
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2700
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Salzburg
Query!
Country [2]
0
0
Belgium
Query!
State/province [2]
0
0
Brussels
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Gent
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Gilly
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Namur
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Calgary
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Montreal
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Ottawa
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
Quebec
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
Toronto
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Beijing
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Hong Kong
Query!
Country [13]
0
0
China
Query!
State/province [13]
0
0
Shangai
Query!
Country [14]
0
0
Czech Republic
Query!
State/province [14]
0
0
Karlove
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Grenoble
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Lille
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Nantes
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Nimes
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Paris
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Rennes
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Saint Denis
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Bad Nauheim
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Bernau
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Heidelberg
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Neuss
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Siegburg
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Ulm
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Wuppertal
Query!
Country [29]
0
0
Greece
Query!
State/province [29]
0
0
Athens
Query!
Country [30]
0
0
India
Query!
State/province [30]
0
0
Ahmedabad
Query!
Country [31]
0
0
India
Query!
State/province [31]
0
0
Chennai
Query!
Country [32]
0
0
India
Query!
State/province [32]
0
0
Delhi
Query!
Country [33]
0
0
India
Query!
State/province [33]
0
0
Kolkata
Query!
Country [34]
0
0
India
Query!
State/province [34]
0
0
New Delhi
Query!
Country [35]
0
0
India
Query!
State/province [35]
0
0
Pune
Query!
Country [36]
0
0
Ireland
Query!
State/province [36]
0
0
Dublin
Query!
Country [37]
0
0
Ireland
Query!
State/province [37]
0
0
Galway
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Jerusalem
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Ramat Gan
Query!
Country [40]
0
0
Israel
Query!
State/province [40]
0
0
Tel-Aviv
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Arezzo
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Bergamo
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Brescia
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Cagliari
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Mestre
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Mirano
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Padova
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Pavia
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Roma
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Salerno
Query!
Country [51]
0
0
Malaysia
Query!
State/province [51]
0
0
Kuala Lumpur
Query!
Country [52]
0
0
Malaysia
Query!
State/province [52]
0
0
Kuching
Query!
Country [53]
0
0
Netherlands
Query!
State/province [53]
0
0
Alkmaar
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Eindhoven
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Rotterdam
Query!
Country [56]
0
0
New Zealand
Query!
State/province [56]
0
0
Christchurch
Query!
Country [57]
0
0
Portugal
Query!
State/province [57]
0
0
Lisboa
Query!
Country [58]
0
0
Portugal
Query!
State/province [58]
0
0
Lisbon
Query!
Country [59]
0
0
Singapore
Query!
State/province [59]
0
0
Singapore
Query!
Country [60]
0
0
South Africa
Query!
State/province [60]
0
0
Johannesburg
Query!
Country [61]
0
0
South Africa
Query!
State/province [61]
0
0
Vergelegen
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Barcelona
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Cadiz
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Madrid
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Murcia
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Palma de Mallorca
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
San Sebastian
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Santander
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Vigo
Query!
Country [70]
0
0
Sweden
Query!
State/province [70]
0
0
Uppsala
Query!
Country [71]
0
0
Switzerland
Query!
State/province [71]
0
0
Lausanne
Query!
Country [72]
0
0
Thailand
Query!
State/province [72]
0
0
Bangkok
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
Brighton
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
Leicester
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
London
Query!
Country [76]
0
0
United Kingdom
Query!
State/province [76]
0
0
Manchester
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Abbott Medical Devices
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00402272
Query!
Trial related presentations / publications
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. 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Eberhard Grube, MD
Query!
Address
0
0
The Heart Center, Siegburg, Germany
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00402272
Download to PDF