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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00496938




Registration number
NCT00496938
Ethics application status
Date submitted
3/07/2007
Date registered
6/07/2007
Date last updated
13/05/2015

Titles & IDs
Public title
XIENCE V: SPIRIT WOMEN
Scientific title
A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
Secondary ID [1] 0 0
07-377
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Stenosis 0 0
Coronary Arteriosclerosis 0 0
Coronary Artery Disease 0 0
Coronary Artery Restenosis 0 0
Total Coronary Occlusion 0 0
Stent Thrombosis 0 0
Vascular Disease 0 0
Myocardial Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XIENCE V®/ XIENCE PRIME™

Other: 1 - Observational cohort using an all-comers design


Treatment: Devices: XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
Timepoint [1] 0 0
at 1 year
Secondary outcome [1] 0 0
Acute Success (Clinical Device Success and Clinical Procedure Success)
Timepoint [1] 0 0
Acute
Secondary outcome [2] 0 0
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Timepoint [2] 0 0
at 30 days
Secondary outcome [3] 0 0
Adjudicated revascularization (TLR/TVR/all revascularizations)
Timepoint [3] 0 0
at 30 days
Secondary outcome [4] 0 0
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Timepoint [4] 0 0
at 30 days
Secondary outcome [5] 0 0
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Timepoint [5] 0 0
at 30 days
Secondary outcome [6] 0 0
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Timepoint [6] 0 0
at 30 days
Secondary outcome [7] 0 0
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Timepoint [7] 0 0
at 30 days
Secondary outcome [8] 0 0
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Timepoint [8] 0 0
at 240 Days
Secondary outcome [9] 0 0
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Timepoint [9] 0 0
at 1 Year
Secondary outcome [10] 0 0
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Timepoint [10] 0 0
at 2 Years
Secondary outcome [11] 0 0
Adjudicated revascularization (TLR/TVR/all revascularizations)
Timepoint [11] 0 0
at 240 Days
Secondary outcome [12] 0 0
Adjudicated revascularization (TLR/TVR/all revascularizations)
Timepoint [12] 0 0
at 1 year
Secondary outcome [13] 0 0
Adjudicated revascularization (TLR/TVR/all revascularizations)
Timepoint [13] 0 0
at 2 years
Secondary outcome [14] 0 0
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Timepoint [14] 0 0
at 240 Days
Secondary outcome [15] 0 0
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Timepoint [15] 0 0
at 1 Year
Secondary outcome [16] 0 0
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Timepoint [16] 0 0
at 2 Years
Secondary outcome [17] 0 0
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Timepoint [17] 0 0
at 240 Days
Secondary outcome [18] 0 0
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Timepoint [18] 0 0
at 1 Year
Secondary outcome [19] 0 0
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Timepoint [19] 0 0
at 2 Years
Secondary outcome [20] 0 0
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Timepoint [20] 0 0
at 240 Days
Secondary outcome [21] 0 0
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Timepoint [21] 0 0
at 1 Year
Secondary outcome [22] 0 0
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Timepoint [22] 0 0
at 2 years
Secondary outcome [23] 0 0
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Timepoint [23] 0 0
at 240 Days
Secondary outcome [24] 0 0
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Timepoint [24] 0 0
at 1 year
Secondary outcome [25] 0 0
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Timepoint [25] 0 0
at 2 Years

Eligibility
Key inclusion criteria
General

* Patient must be female.
* Patient must be at least 18 years of age.
* Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or 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.
* Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
* Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
* Patient must agree to undergo all CIP-required follow-up examinations.
* Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic

* Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study stents.
* Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy).
* Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
* Target lesion greater than or equal to 28 mm in length by visual estimate.

General
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
* Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
* Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
* Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
* Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

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
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
1600
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Northern Hospital - Epping
Recruitment hospital [2] 0 0
Liverpool Hospital - New South Wales
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
2170 - New South Wales
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
St. Poelten
Country [3] 0 0
Austria
State/province [3] 0 0
Wels
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Charleroi
Country [7] 0 0
Belgium
State/province [7] 0 0
Roeselare
Country [8] 0 0
Brazil
State/province [8] 0 0
Belo Horizonte
Country [9] 0 0
Brazil
State/province [9] 0 0
Porto Alegre
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
China
State/province [11] 0 0
Hong Kong
Country [12] 0 0
China
State/province [12] 0 0
Beijing
Country [13] 0 0
China
State/province [13] 0 0
Guangzhou
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
Denmark
State/province [15] 0 0
Copenhagen
Country [16] 0 0
France
State/province [16] 0 0
Avignon Cedex 9
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Brest Cedex
Country [19] 0 0
France
State/province [19] 0 0
Dijon
Country [20] 0 0
France
State/province [20] 0 0
Massy
Country [21] 0 0
France
State/province [21] 0 0
Montpellier
Country [22] 0 0
France
State/province [22] 0 0
RENNES Cedex
Country [23] 0 0
France
State/province [23] 0 0
Rouen
Country [24] 0 0
Germany
State/province [24] 0 0
Bad Oeynhausen
Country [25] 0 0
Germany
State/province [25] 0 0
Bad Segeberg
Country [26] 0 0
Germany
State/province [26] 0 0
Coburg
Country [27] 0 0
Germany
State/province [27] 0 0
Dachau
Country [28] 0 0
Germany
State/province [28] 0 0
Dresden
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Ludwigshafen
Country [32] 0 0
Germany
State/province [32] 0 0
Mainz
Country [33] 0 0
Germany
State/province [33] 0 0
Trier
Country [34] 0 0
Germany
State/province [34] 0 0
Villingen-Schwenningen
Country [35] 0 0
Greece
State/province [35] 0 0
Athens
Country [36] 0 0
Greece
State/province [36] 0 0
Thessaloniki
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Pécs
Country [39] 0 0
India
State/province [39] 0 0
Andhar Pradesh
Country [40] 0 0
India
State/province [40] 0 0
Andhra Pradesh
Country [41] 0 0
India
State/province [41] 0 0
Lucknow
Country [42] 0 0
India
State/province [42] 0 0
New Delhi
Country [43] 0 0
Israel
State/province [43] 0 0
Holon
Country [44] 0 0
Italy
State/province [44] 0 0
Lecco
Country [45] 0 0
Italy
State/province [45] 0 0
Milano
Country [46] 0 0
Italy
State/province [46] 0 0
Milan
Country [47] 0 0
Italy
State/province [47] 0 0
Modena
Country [48] 0 0
Italy
State/province [48] 0 0
Palermo
Country [49] 0 0
Italy
State/province [49] 0 0
Perugia
Country [50] 0 0
Italy
State/province [50] 0 0
Pisa
Country [51] 0 0
Italy
State/province [51] 0 0
Reggio Emilia
Country [52] 0 0
Italy
State/province [52] 0 0
Rome
Country [53] 0 0
Italy
State/province [53] 0 0
Rozzano
Country [54] 0 0
Italy
State/province [54] 0 0
San Donato
Country [55] 0 0
Latvia
State/province [55] 0 0
Riga
Country [56] 0 0
Malaysia
State/province [56] 0 0
Lembah Pantai
Country [57] 0 0
Netherlands
State/province [57] 0 0
Amsterdam
Country [58] 0 0
Netherlands
State/province [58] 0 0
Breda
Country [59] 0 0
Netherlands
State/province [59] 0 0
Nieuwegein
Country [60] 0 0
Norway
State/province [60] 0 0
Bergen
Country [61] 0 0
Norway
State/province [61] 0 0
Feiring
Country [62] 0 0
Poland
State/province [62] 0 0
Ustron
Country [63] 0 0
Poland
State/province [63] 0 0
Warsaw
Country [64] 0 0
Portugal
State/province [64] 0 0
Lisboa
Country [65] 0 0
Portugal
State/province [65] 0 0
Porto
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
South Africa
State/province [67] 0 0
Bloemfontein
Country [68] 0 0
South Africa
State/province [68] 0 0
Pretoria
Country [69] 0 0
Spain
State/province [69] 0 0
Alicante
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Zaragoza
Country [73] 0 0
Switzerland
State/province [73] 0 0
Bern
Country [74] 0 0
Switzerland
State/province [74] 0 0
Geneve
Country [75] 0 0
Switzerland
State/province [75] 0 0
Lugano
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London
Country [77] 0 0
Venezuela
State/province [77] 0 0
Caracas

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 the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.
Trial website
https://clinicaltrials.gov/study/NCT00496938
Trial related presentations / publications
Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Marie-Claude Morice
Address 0 0
Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
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/study/NCT00496938