Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
05-369
Universal Trial Number (UTN)
Trial acronym
SPIRIT V
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Disease 0 0
Coronary Artery Disease 0 0
Coronary Restenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) .
Timepoint [1] 0 0
at 30 days
Secondary outcome [1] 0 0
SPIRIT V Registry: Acute Success (Clinical Procedure Success)
Timepoint [1] 0 0
Acute
Secondary outcome [2] 0 0
SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible)
Timepoint [2] 0 0
at 30 days, 1 and 2 years
Secondary outcome [3] 0 0
SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization)
Timepoint [3] 0 0
at 30 days, 1 and 2 years
Secondary outcome [4] 0 0
SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR
Timepoint [4] 0 0
at 30 days, 1 and 2 years
Secondary outcome [5] 0 0
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR
Timepoint [5] 0 0
at 30 days, 1 and 2 years
Secondary outcome [6] 0 0
SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR)
Timepoint [6] 0 0
at 30 days, 1 and 2 years
Secondary outcome [7] 0 0
SPIRIT V Registry: Acute Success (Clinical Device Success)
Timepoint [7] 0 0
Acute

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
2700
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Gilly
Country [5] 0 0
Belgium
State/province [5] 0 0
Namur
Country [6] 0 0
Canada
State/province [6] 0 0
Calgary
Country [7] 0 0
Canada
State/province [7] 0 0
Montreal
Country [8] 0 0
Canada
State/province [8] 0 0
Ottawa
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Toronto
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Hong Kong
Country [13] 0 0
China
State/province [13] 0 0
Shangai
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Karlove
Country [15] 0 0
France
State/province [15] 0 0
Grenoble
Country [16] 0 0
France
State/province [16] 0 0
Lille
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Nimes
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Rennes
Country [21] 0 0
France
State/province [21] 0 0
Saint Denis
Country [22] 0 0
Germany
State/province [22] 0 0
Bad Nauheim
Country [23] 0 0
Germany
State/province [23] 0 0
Bernau
Country [24] 0 0
Germany
State/province [24] 0 0
Heidelberg
Country [25] 0 0
Germany
State/province [25] 0 0
Neuss
Country [26] 0 0
Germany
State/province [26] 0 0
Siegburg
Country [27] 0 0
Germany
State/province [27] 0 0
Ulm
Country [28] 0 0
Germany
State/province [28] 0 0
Wuppertal
Country [29] 0 0
Greece
State/province [29] 0 0
Athens
Country [30] 0 0
India
State/province [30] 0 0
Ahmedabad
Country [31] 0 0
India
State/province [31] 0 0
Chennai
Country [32] 0 0
India
State/province [32] 0 0
Delhi
Country [33] 0 0
India
State/province [33] 0 0
Kolkata
Country [34] 0 0
India
State/province [34] 0 0
New Delhi
Country [35] 0 0
India
State/province [35] 0 0
Pune
Country [36] 0 0
Ireland
State/province [36] 0 0
Dublin
Country [37] 0 0
Ireland
State/province [37] 0 0
Galway
Country [38] 0 0
Israel
State/province [38] 0 0
Jerusalem
Country [39] 0 0
Israel
State/province [39] 0 0
Ramat Gan
Country [40] 0 0
Israel
State/province [40] 0 0
Tel-Aviv
Country [41] 0 0
Italy
State/province [41] 0 0
Arezzo
Country [42] 0 0
Italy
State/province [42] 0 0
Bergamo
Country [43] 0 0
Italy
State/province [43] 0 0
Brescia
Country [44] 0 0
Italy
State/province [44] 0 0
Cagliari
Country [45] 0 0
Italy
State/province [45] 0 0
Mestre
Country [46] 0 0
Italy
State/province [46] 0 0
Mirano
Country [47] 0 0
Italy
State/province [47] 0 0
Padova
Country [48] 0 0
Italy
State/province [48] 0 0
Pavia
Country [49] 0 0
Italy
State/province [49] 0 0
Roma
Country [50] 0 0
Italy
State/province [50] 0 0
Salerno
Country [51] 0 0
Malaysia
State/province [51] 0 0
Kuala Lumpur
Country [52] 0 0
Malaysia
State/province [52] 0 0
Kuching
Country [53] 0 0
Netherlands
State/province [53] 0 0
Alkmaar
Country [54] 0 0
Netherlands
State/province [54] 0 0
Eindhoven
Country [55] 0 0
Netherlands
State/province [55] 0 0
Rotterdam
Country [56] 0 0
New Zealand
State/province [56] 0 0
Christchurch
Country [57] 0 0
Portugal
State/province [57] 0 0
Lisboa
Country [58] 0 0
Portugal
State/province [58] 0 0
Lisbon
Country [59] 0 0
Singapore
State/province [59] 0 0
Singapore
Country [60] 0 0
South Africa
State/province [60] 0 0
Johannesburg
Country [61] 0 0
South Africa
State/province [61] 0 0
Vergelegen
Country [62] 0 0
Spain
State/province [62] 0 0
Barcelona
Country [63] 0 0
Spain
State/province [63] 0 0
Cadiz
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Murcia
Country [66] 0 0
Spain
State/province [66] 0 0
Palma de Mallorca
Country [67] 0 0
Spain
State/province [67] 0 0
San Sebastian
Country [68] 0 0
Spain
State/province [68] 0 0
Santander
Country [69] 0 0
Spain
State/province [69] 0 0
Vigo
Country [70] 0 0
Sweden
State/province [70] 0 0
Uppsala
Country [71] 0 0
Switzerland
State/province [71] 0 0
Lausanne
Country [72] 0 0
Thailand
State/province [72] 0 0
Bangkok
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Brighton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Leicester
Country [75] 0 0
United Kingdom
State/province [75] 0 0
London
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Manchester
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00402272
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eberhard Grube, MD
Address 0 0
The Heart Center, Siegburg, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00402272