XIENCE V: SPIRIT WOMEN

May 12, 2015 updated by: Abbott Medical Devices

A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
Time Frame: at 1 year
at 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (ESTIMATE)

July 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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