XIENCE V: SPIRIT WOMEN

NCT00496938 | Completed Phase 4 DMC

• 1 other identifier: 07-377
• Study Type: interventional
• Target: 1,600
• Locations: 25 countries
• Sites: 93

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  at 1 year

Secondary Outcomes (25)

• Acute Success (Clinical Device Success and Clinical Procedure Success)

  Acute

• Adjudicated Stent Thrombosis (Definite, Probable, Possible)

  at 30 days

• Adjudicated revascularization (TLR/TVR/all revascularizations)

  at 30 days

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

  at 30 days

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

  at 30 days

Study Arms (1)

1

OTHER

Observational cohort using an all-comers design

Device: XIENCE V®/ XIENCE PRIME™

Interventions

XIENCE V®/ XIENCE PRIME™ DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (95)

Hosital Italiano de Buenos Aires - Cardiologia

Buenos Aires, Buenos Aires, 1181, Argentina

Location

Instituto Cardiovascular de Buenos Aires-ICBA

Buenos Aires, 1428, Argentina

Location

The Northern Hospital

Epping, 3076, Australia

Location

Liverpool Hospital

New South Wales, 2170, Australia

Location

Landesklinikum St. Pölten

Sankt Pölten, 3100, Austria

Location

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

Vienna, 1090, Austria

Location

Klinikum Kreuzschwestern Wels GmbH

Wels, 4600, Austria

Location

Universitair Ziekenhuis Brussel

Brussels, 1090 BXL, Belgium

Location

CHU Charleroi

Charleroi, 6000, Belgium

Location

Heilig Hart Ziekenhuis Roeselare

Roeselare, 8800, Belgium

Location

Hospital Madre Teresa

Belo Horizonte, 30380-090, Brazil

Location

Hospital Moinhos de Ventos-Centro de Cardiologia

Porto Alegre, 04263-000, Brazil

Location

Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

São Paulo, 04012-180, Brazil

Location

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

São Paulo, Brazil

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong, China

Location

Tuen Mun Hospital

Hong Kong, Hong Kong, China

Location

Fu Wai Hospital

Beijing, 100037, China

Location

China People Liberation Army (PLA) General Hospital

Beijing, 100853, China

Location

Guangzhou Army General Hospital

Guangzhou, 510010, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

United Christian Hospital

Hong Kong, China

Location

Shanghai Renji Hospital (East)

Shanghai, 200127, China

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Henri Duffaut

Avignon, 84902, France

Location

Clinique Saint Augustin

Bordeaux, 33000, France

Location

Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Hôpital du Bocage - CHU

Dijon, 21034, France

Location

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

Massy, 91300, France

Location

Hôpital Arnaud de Villeneuve - CHU

Montpellier, 34295, France

Location

Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU

Rennes, 35033, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

Kardiologische Klinik Herz- und Diabeteszentrum

Bad Oeynhausen, 32545, Germany

Location

Segebergerkliniken

Bad Segeberg, 23795, Germany

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

Amper Kliniken-Kreisklinik

Dachau, 85221, Germany

Location

Technische Universität Dresden, Medizinische Klinik II - Kardiologie

Dresden, 01307, Germany

Location

Universitäres Herzzentrum, Medizinische Klinik III

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie

Hanover, 30625, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 63067, Germany

Location

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

Mainz, 55131, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, Germany

Location

Kliniken Villingen

Villingen-Schwenningen, 78050, Germany

Location

Onassis Cardiac Surgery Hospital

Athens, 674, Greece

Location

Cardiology Clinic of Papageorgiou Hospital

Thessaloniki, 56403, Greece

Location

Semmelweis University, Department of Cardiovascular Surgery

Budapest, Hungary

Location

University of Pécs/Medical School/Heart Institute

Pécs, Hungary

Location

Apollo Hospital

Hyderabaad, Andhar Pradesh, 500033, India

Location

CARE Hospital

Hyderabaad, Andhra Pradesh, 500034, India

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, 226014, India

Location

Max Devki Devi Heart & Vascular Insititute, Department of Cardiology

New Delhi, 110017, India

Location

Escorts Heart Institute & Research Centre

New Delhi, 110025, India

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Ospedale A. Manzoni

Lecco, 23900, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

Milan, 20149, Italy

Location

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

Modena, 41100, Italy

Location

Hesperia Hospital

Modena, 41100, Italy

Location

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

Palermo, 90127, Italy

Location

A.O Di Perugia, Ospedale Silvestrini

Perugia, 06122, Italy

Location

Ospedale Cisanello

Pisa, 56127, Italy

Location

Azienda Ospedaliera Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

A.O. Universitaria Tor Vergata, Cardiologia

Rome, 00133, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Instituto Policlinico S. Donato

San Donato, 20097, Italy

Location

Latvian Center of Cardiology, P. Stradina University Hospital

Riga, 1002, Latvia

Location

University Malay Medical Center

Kuala Lumpur, Lembah Pantai, 50603, Malaysia

Location

Het Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, 1091, Netherlands

Location

AMC

Amsterdam, 1105, Netherlands

Location

Amphia Hospital

Breda, 4818, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3430, Netherlands

Location

Haukeland university hospital

Bergen, 5021, Norway

Location

Feiringklinikken AS

Feiring, 2093, Norway

Location

Polsko Amerykanskie-Kliniki Serca American Heart

Ustroń, 43-450, Poland

Location

Institute of Cardiology

Warsaw, 04-628, Poland

Location

Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospitalar Santa Marta

Lisbon, 1649-035, Portugal

Location

Hospital São João

Porto, 4200, Portugal

Location

Bakulev Scientific Center for Cardiovascular Surgery

Moscow, 117047, Russia

Location

Bloemfontein Medi-Clinic

Bloemfontein, 9301, South Africa

Location

Unitas Hospital

Pretoria, 0157, South Africa

Location

Hospital General de Alicante

Alicante, 3010, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos, Hemodynamics Department

Madrid, 28040, Spain

Location

H. Miguel Servet. Zaragoza, Cardiology Service

Zaragoza, 50009, Spain

Location

Inselspital Bern, Kardiologie

Bern, 3010, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Queen Elizabeth Hospital

London, B15 2TH, United Kingdom

Location

Freeman Hospital

London, NE7 7DN, United Kingdom

Location

Hammersmith Hospital

London, W12 OHS, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Centro Medico de Caracas

Caracas, Venezuela

Location

Clinica Santa Sofia

Caracas, Venezuela

Location

Related Publications (2)

• 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.

  PMID: 19072483 BACKGROUND

• 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.

  PMID: 25940520 DERIVED

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Marie-Claude Morice

  Institut Cardiovasculaire Paris Sud (ICPS), Paris, France

  PRINCIPAL INVESTIGATOR

• Stephan Windecker

  University Hospital Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: July 1, 2011
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

GB (4); ZA (2); BR (4); DE (11); PL (2); CN (9); LA (1); GR (2); NL (4); FR (8); ES (5); CH (3); PT (3); IT (12); AR (2); DK (1); HU (2); RU (1); IL (1); AU (3); NO (2); VE (2); IN (5); BE (3); MY (1)