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Coronary Artery StenosisPhase 4NCT00496938

XIENCE V: SPIRIT WOMEN

A Phase 4 study testing XIENCE V®/ XIENCE PRIME™ in people with Coronary Artery Stenosis and Coronary Arteriosclerosis, run by Abbott Medical Devices at 95 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
XIENCE V®/ XIENCE PRIME™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
95 sitesin 26 countries
Study dates
Jul 2007to Jul 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

95 sites in 26 countries.

95 sites in 26 countries

Italy12 sites

  • Ospedale A. Manzoni

    Lecco, 23900

  • Centro Cardiologico Monzino

    Milan, 20138

  • Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

    Milan, 20149

  • Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

    Modena, 41100

  • Hesperia Hospital

    Modena, 41100

  • L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli

    Palermo, 90127

  • A.O Di Perugia, Ospedale Silvestrini

    Perugia, 06122

  • Ospedale Cisanello

    Pisa, 56127

  • Azienda Ospedaliera Santa Maria Nuova

    Reggio Emilia, 42100

  • A.O. Universitaria Tor Vergata, Cardiologia

    Rome, 00133

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Instituto Policlinico S. Donato

    San Donato, 20097

Other trials in Italy

Germany11 sites

  • Kardiologische Klinik Herz- und Diabeteszentrum

    Bad Oeynhausen, 32545

  • Segebergerkliniken

    Bad Segeberg, 23795

  • Klinikum Coburg GmbH

    Coburg, 96450

  • Amper Kliniken-Kreisklinik

    Dachau, 85221

  • Technische Universität Dresden, Medizinische Klinik II - Kardiologie

    Dresden, 01307

  • Universitäres Herzzentrum, Medizinische Klinik III

    Hamburg, 20246

  • Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie

    Hanover, 30625

  • Klinikum Ludwigshafen

    Ludwigshafen, 63067

  • Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik

    Mainz, 55131

  • Krankenhaus der Barmherzigen Brüder

    Trier

  • Kliniken Villingen

    Villingen-Schwenningen, 78050

Other trials in Germany

China9 sites

  • Fu Wai Hospital

    Beijing, 100037

  • China People Liberation Army (PLA) General Hospital

    Beijing, 100853

  • Guangzhou Army General Hospital

    Guangzhou, 510010

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Tuen Mun Hospital

    Hong Kong, Hong Kong

  • United Christian Hospital

    Hong Kong

  • Shanghai Renji Hospital (East)

    Shanghai, 200127

Other trials in China

France8 sites

  • Hôpital Henri Duffaut

    Avignon, 84902

  • Clinique Saint Augustin

    Bordeaux, 33000

  • Hôpital de la Cavale Blanche

    Brest, 29609

  • Hôpital du Bocage - CHU

    Dijon, 21034

  • Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

    Massy, 91300

  • Hôpital Arnaud de Villeneuve - CHU

    Montpellier, 34295

  • Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU

    Rennes, 35033

  • Hôpital Charles Nicolle

    Rouen, 76031

Other trials in France

India5 sites

  • Apollo Hospital

    Hyderabaad, Andhar Pradesh, 500033

  • CARE Hospital

    Hyderabaad, Andhra Pradesh, 500034

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, 226014

  • Max Devki Devi Heart & Vascular Insititute, Department of Cardiology

    New Delhi, 110017

  • Escorts Heart Institute & Research Centre

    New Delhi, 110025

Other trials in India

Spain5 sites

  • Hospital General de Alicante

    Alicante, 3010

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Clinico San Carlos, Hemodynamics Department

    Madrid, 28040

  • H. Miguel Servet. Zaragoza, Cardiology Service

    Zaragoza, 50009

Other trials in Spain

Brazil4 sites

  • Hospital Madre Teresa

    Belo Horizonte, 30380-090

  • Hospital Moinhos de Ventos-Centro de Cardiologia

    Porto Alegre, 04263-000

  • Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

    São Paulo, 04012-180

  • INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP

    São Paulo

Other trials in Brazil

Netherlands4 sites

  • Het Onze Lieve Vrouwe Gasthuis (OLVG)

    Amsterdam, 1091

  • AMC

    Amsterdam, 1105

  • Amphia Hospital

    Breda, 4818

  • St. Antonius Ziekenhuis

    Nieuwegein, 3430

Other trials in Netherlands

United Kingdom4 sites

  • Queen Elizabeth Hospital

    London, B15 2TH

  • Freeman Hospital

    London, NE7 7DN

  • Hammersmith Hospital

    London, W12 OHS

  • St Mary's Hospital

    London, W2 1NY

Other trials in United Kingdom

Austria3 sites

  • Landesklinikum St. Pölten

    Sankt Pölten, 3100

  • Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

    Vienna, 1090

  • Klinikum Kreuzschwestern Wels GmbH

    Wels, 4600

Other trials in Austria

Belgium3 sites

  • Universitair Ziekenhuis Brussel

    Brussels, 1090 BXL

  • CHU Charleroi

    Charleroi, 6000

  • Heilig Hart Ziekenhuis Roeselare

    Roeselare, 8800

Other trials in Belgium

Portugal3 sites

  • Hospital Santa Maria

    Lisbon, 1649-035

  • Hospitalar Santa Marta

    Lisbon, 1649-035

  • Hospital São João

    Porto, 4200

Other trials in Portugal

Switzerland3 sites

  • Inselspital Bern, Kardiologie

    Bern, 3010

  • Hôpitaux Universitaires de Genève

    Geneva, 1211

  • Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

Argentina2 sites

  • Hosital Italiano de Buenos Aires - Cardiologia

    Buenos Aires, Buenos Aires, 1181

  • Instituto Cardiovascular de Buenos Aires-ICBA

    Buenos Aires, 1428

Other trials in Argentina

Australia2 sites

  • The Northern Hospital

    Epping, 3076

  • Liverpool Hospital

    New South Wales, 2170

Other trials in Australia

Greece2 sites

  • Onassis Cardiac Surgery Hospital

    Athens, 674

  • Cardiology Clinic of Papageorgiou Hospital

    Thessaloniki, 56403

Other trials in Greece

Hungary2 sites

  • Semmelweis University, Department of Cardiovascular Surgery

    Budapest

  • University of Pécs/Medical School/Heart Institute

    Pécs

Other trials in Hungary

Norway2 sites

  • Haukeland university hospital

    Bergen, 5021

  • Feiringklinikken AS

    Feiring, 2093

Other trials in Norway

Poland2 sites

  • Polsko Amerykanskie-Kliniki Serca American Heart

    Ustroń, 43-450

  • Institute of Cardiology

    Warsaw, 04-628

Other trials in Poland

South Africa2 sites

  • Bloemfontein Medi-Clinic

    Bloemfontein, 9301

  • Unitas Hospital

    Pretoria, 0157

Other trials in South Africa

Venezuela2 sites

  • Centro Medico de Caracas

    Caracas

  • Clinica Santa Sofia

    Caracas

Other trials in Venezuela

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Israel1 site

  • Wolfson Medical Center

    Holon, 58100

Other trials in Israel

Latvia1 site

  • Latvian Center of Cardiology, P. Stradina University Hospital

    Riga, 1002

Other trials in Latvia

Malaysia1 site

  • University Malay Medical Center

    Kuala Lumpur, Lembah Pantai, 50603

Other trials in Malaysia

Russia1 site

  • Bakulev Scientific Center for Cardiovascular Surgery

    Moscow, 117047

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
XIENCE V®/ XIENCE PRIME™
Keywords
Stents, Angioplasty, Total coronary occlusions, Coronary restenosis, Stent thrombosis, Everolimus
Medical subject headings
Coronary Stenosis, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XIENCE V®/ XIENCE PRIME™Device

    Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

Study groups in NCT00496938
Study groupRoleWhat they receive
1OtherObservational cohort using an all-comers design
Receives: Device: XIENCE V®/ XIENCE PRIME™

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at 1 year

Secondary outcomes (25)

  1. Acute Success (Clinical Device Success and Clinical Procedure Success)

    Measured: Acute

  2. Adjudicated Stent Thrombosis (Definite, Probable, Possible)

    Measured: at 30 days

  3. Adjudicated revascularization (TLR/TVR/all revascularizations)

    Measured: at 30 days

  4. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.

    Measured: at 30 days

  5. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).

    Measured: at 30 days

  6. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.

    Measured: at 30 days

  7. Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

    Measured: at 30 days

  8. Adjudicated Stent Thrombosis (Definite, Probable, Possible)

    Measured: at 240 Days

  9. Adjudicated Stent Thrombosis (Definite, Probable, Possible)

    Measured: at 1 Year

  10. Adjudicated Stent Thrombosis (Definite, Probable, Possible)

    Measured: at 2 Years

  11. Adjudicated revascularization (TLR/TVR/all revascularizations)

    Measured: at 240 Days

  12. Adjudicated revascularization (TLR/TVR/all revascularizations)

    Measured: at 1 year

  13. Adjudicated revascularization (TLR/TVR/all revascularizations)

    Measured: at 2 years

  14. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.

    Measured: at 240 Days

  15. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.

    Measured: at 1 Year

  16. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.

    Measured: at 2 Years

  17. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).

    Measured: at 240 Days

  18. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).

    Measured: at 1 Year

  19. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).

    Measured: at 2 Years

  20. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.

    Measured: at 240 Days

  21. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.

    Measured: at 1 Year

  22. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.

    Measured: at 2 years

  23. Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

    Measured: at 240 Days

  24. Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

    Measured: at 1 year

  25. Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).

    Measured: at 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionAug 2010
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496938
Sponsor's protocol ID
07-377
Status last verified
May 2015
First submitted
3 Jul 2007
Last updated
13 May 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 19072483

  • 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.

    PubMed 25940520

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing XIENCE V®/ XIENCE PRIME™ in people with Coronary Artery Stenosis and Coronary Arteriosclerosis, run by Abbott Medical Devices at 95 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in Italy, Germany, China, France, India and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) (time frame: at 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00496938, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.

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