XIENCE V: SPIRIT WOMEN

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00496938
First received: July 3, 2007
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Coronary Arteriosclerosis
Coronary Artery Disease
Coronary Artery Restenosis
Total Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Device: XIENCE V®/ XIENCE PRIME™
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute Success (Clinical Device Success and Clinical Procedure Success) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 1 Year ] [ Designated as safety issue: Yes ]
  • Adjudicated Stent Thrombosis (Definite, Probable, Possible) [ Time Frame: at 2 Years ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Adjudicated revascularization (TLR/TVR/all revascularizations) [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [ Time Frame: at 1 Year ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [ Time Frame: at 2 Years ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [ Time Frame: at 1 Year ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [ Time Frame: at 2 Years ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [ Time Frame: at 240 Days ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [ Time Frame: at 1 Year ] [ Designated as safety issue: Yes ]
  • Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1600
Study Start Date: July 2007
Study Completion Date: July 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Observational cohort using an all-comers design
Device: XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496938

  Hide Study Locations
Locations
Argentina
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, Argentina, 1428
Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, Argentina, 1181
Australia
The Northern Hospital
Epping, Australia, 3076
Liverpool Hospital
New South Wales, Australia, 2170
Austria
Landesklinikum St. Pölten
St. Poelten, Austria, 3100
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria, 4600
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Wien, Austria, 1090
Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090 BXL
CHU Charleroi
Charleroi, Belgium, 6000
Heilig Hart Ziekenhuis Roeselare
Roeselare, Belgium, 8800
Brazil
Hospital Madre Teresa
Belo Horizonte, Brazil, 30380-090
Hospital Moinhos de Ventos-Centro de Cardiologia
Porto Alegre, Brazil, 04263-000
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Sao Paulo, Brazil, 04012-180
INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP
Sao Paulo, Brazil
China, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong, China
Queen Mary Hospital
Hong Kong, Hong Kong, China
Tuen Mun Hospital
Hong Kong, Hong Kong, China
China, Kowloon
United Christian Hospital
Hong Kong, Kowloon, China
China
China People Liberation Army (PLA) General Hospital
Beijing, China, 100853
Fu Wai Hospital
Beijing, China, 100037
Guangzhou Army General Hospital
Guangzhou, China, 510010
Guangdong Provincial People's Hospital
Guangzhou, China
Shanghai Renji Hospital (East)
Shanghai, China, 200127
Denmark
Rigshospitalet
Copenhagen, Denmark
France
Hôpital Henri Duffaut
Avignon Cedex 9, France, 84902
Clinique Saint Augustin
Bordeaux, France, 33000
Hôpital de la Cavale Blanche
Brest Cedex, France, 29609
Hôpital du Bocage - CHU
Dijon, France, 21034
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
Massy, France, 91300
Hôpital Arnaud de Villeneuve - CHU
Montpellier, France, 34295
Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU
RENNES Cedex, France, 35033
Hôpital Charles Nicolle
Rouen, France, 76031
Germany
Kardiologische Klinik Herz- und Diabeteszentrum
Bad Oeynhausen, Germany, 32545
Segebergerkliniken
Bad Segeberg, Germany, 23795
Klinikum Coburg GmbH
Coburg, Germany, 96450
Amper Kliniken-Kreisklinik
Dachau, Germany, 85221
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
Dresden, Germany, 01307
Universitäres Herzzentrum, Medizinische Klinik III
Hamburg, Germany, 20246
Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie
Hannover, Germany, 30625
Klinikum Ludwigshafen
Ludwigshafen, Germany, 63067
Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik
Mainz, Germany, 55131
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Kliniken Villingen
Villingen-Schwenningen, Germany, 78050
Greece
Onassis Cardiac Surgery Hospital
Athens, Greece, 674
Cardiology Clinic of Papageorgiou Hospital
Thessaloniki, Greece, 56403
Hungary
Semmelweis University, Department of Cardiovascular Surgery
Budapest, Hungary
University of Pécs/Medical School/Heart Institute
Pécs, Hungary
India
Apollo Hospital
Hyderabaad, Andhar Pradesh, India, 500033
CARE Hospital
Hyderabaad, Andhra Pradesh, India, 500034
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, India, 226014
Escorts Heart Institute & Research Centre
New Delhi, India, 110025
Max Devki Devi Heart & Vascular Insititute, Department of Cardiology
New Delhi, India, 110017
Israel
Wolfson Medical Center
Holon, Israel, 58100
Italy
Ospedale A. Manzoni
Lecco, Italy, 23900
Centro Cardiologico Monzino
Milan, Italy, 20138
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
Milano, Italy, 20149
Hesperia Hospital
Modena, Italy, 41100
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
Modena, Italy, 41100
L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli
Palermo, Italy, 90127
A.O Di Perugia, Ospedale Silvestrini
Perugia, Italy, 06122
Ospedale Cisanello
Pisa, Italy, 56127
Azienda Ospedaliera Santa Maria Nuova
Reggio Emilia, Italy, 42100
A.O. Universitaria Tor Vergata, Cardiologia
Rome, Italy, 00133
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Instituto Policlinico S. Donato
San Donato, Italy, 20097
Latvia
Latvian Center of Cardiology, P. Stradina University Hospital
Riga, Latvia, 1002
Malaysia
University Malay Medical Center
Kuala Lumpur, Lembah Pantai, Malaysia, 50603
Netherlands
Het Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands, 1091
AMC
Amsterdam, Netherlands, 1105
Amphia Hospital
Breda, Netherlands, 4818
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430
Norway
Haukeland university hospital
Bergen, Norway, 5021
Feiringklinikken AS
Feiring, Norway, 2093
Poland
Polsko Amerykanskie-Kliniki Serca American Heart
Ustroń, Poland, 43-450
Institute of Cardiology
Warsaw, Poland, 04-628
Portugal
Hospitalar Santa Marta
Lisboa, Portugal, 1649-035
Hospital Santa Maria
Lisboa, Portugal, 1649-035
Hospital São João
Porto, Portugal, 4200
Russian Federation
Bakulev Scientific Center for Cardiovascular Surgery
Moscow, Russian Federation, 117047
South Africa
Bloemfontein Medi-Clinic
Bloemfontein, South Africa, 9301
Unitas Hospital
Pretoria, South Africa, 0157
Spain
Hospital General de Alicante
Alicante, Spain, 3010
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Clinico San Carlos, Hemodynamics Department
Madrid, Spain, 28040
H. Miguel Servet. Zaragoza, Cardiology Service
Zaragoza, Spain, 50009
Switzerland
Inselspital Bern, Kardiologie
Bern, Switzerland, 3010
Hôpitaux Universitaires de Genève
Geneve, Switzerland, 1211
Cardiocentro Ticino
Lugano, Switzerland, 6900
United Kingdom
St Mary's Hospital
London, United Kingdom, W2 1NY
Hammersmith Hospital
London, United Kingdom, W12 OHS
Queen Elizabeth Hospital
London, United Kingdom, B15 2TH
Freeman Hospital
London, United Kingdom, NE7 7DN
Venezuela
Centro Medico de Caracas
Caracas, Venezuela
Clinica Santa Sofia
Caracas, Venezuela
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Marie-Claude Morice Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
Principal Investigator: Stephan Windecker University Hospital Bern, Bern, Switzerland
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00496938     History of Changes
Other Study ID Numbers: 07-377
Study First Received: July 3, 2007
Last Updated: September 26, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Abbott Vascular:
Stents
Angioplasty
Total coronary occlusions
Coronary restenosis
Stent thrombosis
Everolimus

Additional relevant MeSH terms:
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Occlusion
Coronary Stenosis
Coronary Restenosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014