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XIENCE V: SPIRIT WOMEN

Primary Purpose

Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
XIENCE V®/ XIENCE PRIME™
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

General Inclusion Criteria:

  • 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 Inclusion Criteria:

  • 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 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)

Sites / Locations

  • Hosital Italiano de Buenos Aires - Cardiologia
  • Instituto Cardiovascular de Buenos Aires-ICBA
  • The Northern Hospital
  • Liverpool Hospital
  • Landesklinikum St. Pölten
  • Klinikum Kreuzschwestern Wels GmbH
  • Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
  • Universitair Ziekenhuis Brussel
  • CHU Charleroi
  • Heilig Hart Ziekenhuis Roeselare
  • Hospital Madre Teresa
  • Hospital Moinhos de Ventos-Centro de Cardiologia
  • Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
  • INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP
  • Queen Elizabeth Hospital
  • Queen Mary Hospital
  • Tuen Mun Hospital
  • Fu Wai Hospital
  • China People Liberation Army (PLA) General Hospital
  • Guangzhou Army General Hospital
  • Guangdong Provincial People's Hospital
  • United Christian Hospital
  • Shanghai Renji Hospital (East)
  • Rigshospitalet
  • Hôpital Henri Duffaut
  • Clinique Saint Augustin
  • Hôpital de la Cavale Blanche
  • Hôpital du Bocage - CHU
  • Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
  • Hôpital Arnaud de Villeneuve - CHU
  • Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU
  • Hôpital Charles Nicolle
  • Kardiologische Klinik Herz- und Diabeteszentrum
  • Segebergerkliniken
  • Klinikum Coburg GmbH
  • Amper Kliniken-Kreisklinik
  • Technische Universität Dresden, Medizinische Klinik II - Kardiologie
  • Universitäres Herzzentrum, Medizinische Klinik III
  • Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie
  • Klinikum Ludwigshafen
  • Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik
  • Krankenhaus der Barmherzigen Brüder
  • Kliniken Villingen
  • Onassis Cardiac Surgery Hospital
  • Cardiology Clinic of Papageorgiou Hospital
  • Semmelweis University, Department of Cardiovascular Surgery
  • University of Pécs/Medical School/Heart Institute
  • Apollo Hospital
  • CARE Hospital
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • Max Devki Devi Heart & Vascular Insititute, Department of Cardiology
  • Escorts Heart Institute & Research Centre
  • Wolfson Medical Center
  • Ospedale A. Manzoni
  • Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
  • Centro Cardiologico Monzino
  • Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
  • Hesperia Hospital
  • L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli
  • A.O Di Perugia, Ospedale Silvestrini
  • Ospedale Cisanello
  • Azienda Ospedaliera Santa Maria Nuova
  • A.O. Universitaria Tor Vergata, Cardiologia
  • Istituto Clinico Humanitas
  • Instituto Policlinico S. Donato
  • Latvian Center of Cardiology, P. Stradina University Hospital
  • University Malay Medical Center
  • Het Onze Lieve Vrouwe Gasthuis (OLVG)
  • AMC
  • Amphia Hospital
  • St. Antonius Ziekenhuis
  • Haukeland university hospital
  • Feiringklinikken AS
  • Polsko Amerykanskie-Kliniki Serca American Heart
  • Institute of Cardiology
  • Hospital Santa Maria
  • Hospitalar Santa Marta
  • Hospital São João
  • Bakulev Scientific Center for Cardiovascular Surgery
  • Bloemfontein Medi-Clinic
  • Unitas Hospital
  • Hospital General de Alicante
  • Hospital Universitari Germans Trias i Pujol
  • Hospital General Universitario Gregorio Marañón
  • Hospital Clinico San Carlos, Hemodynamics Department
  • H. Miguel Servet. Zaragoza, Cardiology Service
  • Inselspital Bern, Kardiologie
  • Hôpitaux Universitaires de Genève
  • Cardiocentro Ticino
  • Queen Elizabeth Hospital
  • Freeman Hospital
  • Hammersmith Hospital
  • St Mary's Hospital
  • Centro Medico de Caracas
  • Clinica Santa Sofia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Observational cohort using an all-comers design

Outcomes

Primary Outcome Measures

Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)

Secondary Outcome Measures

Acute Success (Clinical Device Success and Clinical Procedure Success)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Adjudicated revascularization (TLR/TVR/all revascularizations)
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Adjudicated revascularization (TLR/TVR/all revascularizations)
Adjudicated revascularization (TLR/TVR/all revascularizations)
Adjudicated revascularization (TLR/TVR/all revascularizations)
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

Full Information

First Posted
July 3, 2007
Last Updated
May 12, 2015
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00496938
Brief Title
XIENCE V: SPIRIT WOMEN
Official Title
A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
SPIRIT Women Single-Arm Study: A prospective, open label, single arm, multi-center study evaluating performance of the XIENCE V® and XIENCE PRIME™ EECSS in the treatment of female patients with coronary artery lesions, per its Instructions for Use (IFU). 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 Women study after 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis, Total Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia
Keywords
Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Observational cohort using an all-comers design
Intervention Type
Device
Intervention Name(s)
XIENCE V®/ XIENCE PRIME™
Intervention Description
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Primary Outcome Measure Information:
Title
Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Acute Success (Clinical Device Success and Clinical Procedure Success)
Time Frame
Acute
Title
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time Frame
at 30 days
Title
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time Frame
at 30 days
Title
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time Frame
at 30 days
Title
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time Frame
at 30 days
Title
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time Frame
at 30 days
Title
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time Frame
at 30 days
Title
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time Frame
at 240 Days
Title
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time Frame
at 1 Year
Title
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time Frame
at 2 Years
Title
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time Frame
at 240 Days
Title
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time Frame
at 1 year
Title
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time Frame
at 2 years
Title
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time Frame
at 240 Days
Title
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time Frame
at 1 Year
Title
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time Frame
at 2 Years
Title
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time Frame
at 240 Days
Title
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time Frame
at 1 Year
Title
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time Frame
at 2 Years
Title
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time Frame
at 240 Days
Title
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time Frame
at 1 Year
Title
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time Frame
at 2 years
Title
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time Frame
at 240 Days
Title
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time Frame
at 1 year
Title
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time Frame
at 2 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria: 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 Inclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Claude Morice
Organizational Affiliation
Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Windecker
Organizational Affiliation
University Hospital Bern, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hosital Italiano de Buenos Aires - Cardiologia
City
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Instituto Cardiovascular de Buenos Aires-ICBA
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
The Northern Hospital
City
Epping
ZIP/Postal Code
3076
Country
Australia
Facility Name
Liverpool Hospital
City
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Landesklinikum St. Pölten
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Klinikum Kreuzschwestern Wels GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090 BXL
Country
Belgium
Facility Name
CHU Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis Roeselare
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Hospital Madre Teresa
City
Belo Horizonte
ZIP/Postal Code
30380-090
Country
Brazil
Facility Name
Hospital Moinhos de Ventos-Centro de Cardiologia
City
Porto Alegre
ZIP/Postal Code
04263-000
Country
Brazil
Facility Name
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
City
Sao Paulo
ZIP/Postal Code
04012-180
Country
Brazil
Facility Name
INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP
City
Sao Paulo
Country
Brazil
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China
Facility Name
Tuen Mun Hospital
City
Hong Kong
State/Province
Hong Kong
Country
China
Facility Name
Fu Wai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
China People Liberation Army (PLA) General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Guangzhou Army General Hospital
City
Guangzhou
ZIP/Postal Code
510010
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
Country
China
Facility Name
United Christian Hospital
City
Hong Kong
Country
China
Facility Name
Shanghai Renji Hospital (East)
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hôpital Henri Duffaut
City
Avignon Cedex 9
ZIP/Postal Code
84902
Country
France
Facility Name
Clinique Saint Augustin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital de la Cavale Blanche
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital du Bocage - CHU
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Hôpital Arnaud de Villeneuve - CHU
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU
City
RENNES Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Kardiologische Klinik Herz- und Diabeteszentrum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Segebergerkliniken
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Klinikum Coburg GmbH
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Amper Kliniken-Kreisklinik
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitäres Herzzentrum, Medizinische Klinik III
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
63067
Country
Germany
Facility Name
Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Trier
Country
Germany
Facility Name
Kliniken Villingen
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
Onassis Cardiac Surgery Hospital
City
Athens
ZIP/Postal Code
674
Country
Greece
Facility Name
Cardiology Clinic of Papageorgiou Hospital
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
Facility Name
Semmelweis University, Department of Cardiovascular Surgery
City
Budapest
Country
Hungary
Facility Name
University of Pécs/Medical School/Heart Institute
City
Pécs
Country
Hungary
Facility Name
Apollo Hospital
City
Hyderabaad
State/Province
Andhar Pradesh
ZIP/Postal Code
500033
Country
India
Facility Name
CARE Hospital
City
Hyderabaad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences
City
Lucknow
ZIP/Postal Code
226014
Country
India
Facility Name
Max Devki Devi Heart & Vascular Insititute, Department of Cardiology
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Escorts Heart Institute & Research Centre
City
New Delhi
ZIP/Postal Code
110025
Country
India
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Ospedale A. Manzoni
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
Facility Name
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Hesperia Hospital
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
A.O Di Perugia, Ospedale Silvestrini
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Ospedale Cisanello
City
Pisa
ZIP/Postal Code
56127
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
A.O. Universitaria Tor Vergata, Cardiologia
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Instituto Policlinico S. Donato
City
San Donato
ZIP/Postal Code
20097
Country
Italy
Facility Name
Latvian Center of Cardiology, P. Stradina University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
University Malay Medical Center
City
Kuala Lumpur
State/Province
Lembah Pantai
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Het Onze Lieve Vrouwe Gasthuis (OLVG)
City
Amsterdam
ZIP/Postal Code
1091
Country
Netherlands
Facility Name
AMC
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4818
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3430
Country
Netherlands
Facility Name
Haukeland university hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Feiringklinikken AS
City
Feiring
ZIP/Postal Code
2093
Country
Norway
Facility Name
Polsko Amerykanskie-Kliniki Serca American Heart
City
Ustroń
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Institute of Cardiology
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospitalar Santa Marta
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital São João
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Bakulev Scientific Center for Cardiovascular Surgery
City
Moscow
ZIP/Postal Code
117047
Country
Russian Federation
Facility Name
Bloemfontein Medi-Clinic
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Unitas Hospital
City
Pretoria
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Hospital General de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico San Carlos, Hemodynamics Department
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
H. Miguel Servet. Zaragoza, Cardiology Service
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Inselspital Bern, Kardiologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Queen Elizabeth Hospital
City
London
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Freeman Hospital
City
London
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Centro Medico de Caracas
City
Caracas
Country
Venezuela
Facility Name
Clinica Santa Sofia
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
19072483
Citation
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.
Results Reference
background
PubMed Identifier
25940520
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.
Results Reference
derived

Learn more about this trial

XIENCE V: SPIRIT WOMEN

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