XIENCE V: SPIRIT WOMEN

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496938
• Other study ID #: 07-377
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2007
• Last updated: May 12, 2015
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: May 2015
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical 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 population undergoing stent implantation with a XIENCE stent.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: July 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Artery Restenosis
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Occlusion
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia
• Stent Thrombosis
• Thrombosis
• Total Coronary Occlusion
• Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Argentina	Hosital Italiano de Buenos Aires - Cardiologia	Buenos Aires
Argentina	Instituto Cardiovascular de Buenos Aires-ICBA	Buenos Aires
Australia	The Northern Hospital	Epping
Australia	Liverpool Hospital	New South Wales
Austria	Landesklinikum St. Pölten	St. Poelten
Austria	Klinikum Kreuzschwestern Wels GmbH	Wels
Austria	Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II	Wien
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	CHU Charleroi	Charleroi
Belgium	Heilig Hart Ziekenhuis Roeselare	Roeselare
Brazil	Hospital Madre Teresa	Belo Horizonte
Brazil	Hospital Moinhos de Ventos-Centro de Cardiologia	Porto Alegre
Brazil	INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP	Sao Paulo
Brazil	Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia	Sao Paulo
China	China People Liberation Army (PLA) General Hospital	Beijing
China	Fu Wai Hospital	Beijing
China	Guangdong Provincial People's Hospital	Guangzhou
China	Guangzhou Army General Hospital	Guangzhou
China	Queen Elizabeth Hospital	Hong Kong	Hong Kong
China	Queen Mary Hospital	Hong Kong	Hong Kong
China	Tuen Mun Hospital	Hong Kong	Hong Kong
China	United Christian Hospital	Hong Kong
China	Shanghai Renji Hospital (East)	Shanghai
Denmark	Rigshospitalet	Copenhagen
France	Hôpital Henri Duffaut	Avignon Cedex 9
France	Clinique Saint Augustin	Bordeaux
France	Hôpital de la Cavale Blanche	Brest Cedex
France	Hôpital du Bocage - CHU	Dijon
France	Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud	Massy
France	Hôpital Arnaud de Villeneuve - CHU	Montpellier
France	Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU	RENNES Cedex
France	Hôpital Charles Nicolle	Rouen
Germany	Kardiologische Klinik Herz- und Diabeteszentrum	Bad Oeynhausen
Germany	Segebergerkliniken	Bad Segeberg
Germany	Klinikum Coburg GmbH	Coburg
Germany	Amper Kliniken-Kreisklinik	Dachau
Germany	Technische Universität Dresden, Medizinische Klinik II - Kardiologie	Dresden
Germany	Universitäres Herzzentrum, Medizinische Klinik III	Hamburg
Germany	Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie	Hannover
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik	Mainz
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Germany	Kliniken Villingen	Villingen-Schwenningen
Greece	Onassis Cardiac Surgery Hospital	Athens
Greece	Cardiology Clinic of Papageorgiou Hospital	Thessaloniki
Hungary	Semmelweis University, Department of Cardiovascular Surgery	Budapest
Hungary	University of Pécs/Medical School/Heart Institute	Pécs
India	Apollo Hospital	Hyderabaad	Andhar Pradesh
India	CARE Hospital	Hyderabaad	Andhra Pradesh
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow
India	Escorts Heart Institute & Research Centre	New Delhi
India	Max Devki Devi Heart & Vascular Insititute, Department of Cardiology	New Delhi
Israel	Wolfson Medical Center	Holon
Italy	Ospedale A. Manzoni	Lecco
Italy	Centro Cardiologico Monzino	Milan
Italy	Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO	Milano
Italy	Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena	Modena
Italy	Hesperia Hospital	Modena
Italy	L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli	Palermo
Italy	A.O Di Perugia, Ospedale Silvestrini	Perugia
Italy	Ospedale Cisanello	Pisa
Italy	Azienda Ospedaliera Santa Maria Nuova	Reggio Emilia
Italy	A.O. Universitaria Tor Vergata, Cardiologia	Rome
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Instituto Policlinico S. Donato	San Donato
Latvia	Latvian Center of Cardiology, P. Stradina University Hospital	Riga
Malaysia	University Malay Medical Center	Kuala Lumpur	Lembah Pantai
Netherlands	AMC	Amsterdam
Netherlands	Het Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Norway	Haukeland university hospital	Bergen
Norway	Feiringklinikken AS	Feiring
Poland	Polsko Amerykanskie-Kliniki Serca American Heart	Ustron
Poland	Institute of Cardiology	Warsaw
Portugal	Hospital Santa Maria	Lisboa
Portugal	Hospitalar Santa Marta	Lisboa
Portugal	Hospital São João	Porto
Russian Federation	Bakulev Scientific Center for Cardiovascular Surgery	Moscow
South Africa	Bloemfontein Medi-Clinic	Bloemfontein
South Africa	Unitas Hospital	Pretoria
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Hospital Clinico San Carlos, Hemodynamics Department	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	H. Miguel Servet. Zaragoza, Cardiology Service	Zaragoza
Switzerland	Inselspital Bern, Kardiologie	Bern
Switzerland	Hôpitaux Universitaires de Genève	Geneve
Switzerland	Cardiocentro Ticino	Lugano
United Kingdom	Freeman Hospital	London
United Kingdom	Hammersmith Hospital	London
United Kingdom	Queen Elizabeth Hospital	London
United Kingdom	St Mary's Hospital	London
Venezuela	Centro Medico de Caracas	Caracas
Venezuela	Clinica Santa Sofia	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  China,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Latvia,  Malaysia,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom,  Venezuela, 

References & Publications (1)

Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond Engl). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)		at 1 year	Yes
Secondary	Acute Success (Clinical Device Success and Clinical Procedure Success)		Acute	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable, Possible)		at 30 days	Yes
Secondary	Adjudicated revascularization (TLR/TVR/all revascularizations)		at 30 days	Yes
Secondary	Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.		at 30 days	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).		at 30 days	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.		at 30 days	Yes
Secondary	Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 30 days	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable, Possible)		at 240 Days	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable, Possible)		at 1 Year	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable, Possible)		at 2 Years	Yes
Secondary	Adjudicated revascularization (TLR/TVR/all revascularizations)		at 240 Days	Yes
Secondary	Adjudicated revascularization (TLR/TVR/all revascularizations)		at 1 year	Yes
Secondary	Adjudicated revascularization (TLR/TVR/all revascularizations)		at 2 years	Yes
Secondary	Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.		at 240 Days	Yes
Secondary	Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.		at 1 Year	Yes
Secondary	Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.		at 2 Years	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).		at 240 Days	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).		at 1 Year	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).		at 2 Years	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.		at 240 Days	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.		at 1 Year	Yes
Secondary	Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.		at 2 years	Yes
Secondary	Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 240 Days	Yes
Secondary	Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 1 year	Yes
Secondary	Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 2 Years	Yes