Clinical trial NCT00496938: XIENCE V: SPIRIT WOMEN
Official title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-07-06
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
timeFrame: at 1 year
Secondary outcomes:
measure: Acute Success (Clinical Device Success and Clinical Procedure Success)
timeFrame: Acute
measure: Adjudicated Stent Thrombosis (Definite, Probable, Possible)
timeFrame: at 30 days
measure: Adjudicated revascularization (TLR/TVR/all revascularizations)
timeFrame: at 30 days
measure: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
timeFrame: at 30 days
measure: Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
timeFrame: at 30 days
measure: Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
timeFrame: at 30 days
measure: Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
timeFrame: at 30 days
measure: Adjudicated Stent Thrombosis (Definite, Probable, Possible)
timeFrame: at 240 Days
measure: Adjudicated Stent Thrombosis (Definite, Probable, Possible)
timeFrame: at 1 Year
measure: Adjudicated Stent Thrombosis (Definite, Probable, Possible)
timeFrame: at 2 Years
measure: Adjudicated revascularization (TLR/TVR/all revascularizations)
timeFrame: at 240 Days
measure: Adjudicated revascularization (TLR/TVR/all revascularizations)
timeFrame: at 1 year
measure: Adjudicated revascularization (TLR/TVR/all revascularizations)
timeFrame: at 2 years
measure: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
timeFrame: at 240 Days
measure: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
timeFrame: at 1 Year
measure: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
timeFrame: at 2 Years
measure: Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
timeFrame: at 240 Days
measure: Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
timeFrame: at 1 Year
measure: Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
timeFrame: at 2 Years
measure: Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
timeFrame: at 240 Days
measure: Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
timeFrame: at 1 Year
measure: Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
timeFrame: at 2 years
measure: Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
timeFrame: at 240 Days
measure: Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
timeFrame: at 1 year
measure: Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
timeFrame: at 2 Years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hosital Italiano de Buenos Aires - Cardiologia
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires-ICBA
city: Epping
country: Australia
facility: The Northern Hospital
city: New South Wales
country: Australia
facility: Liverpool Hospital
city: St. Poelten
country: Austria
facility: Landesklinikum St. Pölten
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis Roeselare
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Ventos-Centro de Cardiologia
city: Sao Paulo
country: Brazil
facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
city: Sao Paulo
country: Brazil
facility: INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
state: Hong Kong
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
city: Hong Kong
country: China
facility: Tuen Mun Hospital
state: Hong Kong
city: Beijing
country: China
facility: Fu Wai Hospital
city: Beijing
country: China
facility: China People Liberation Army (PLA) General Hospital
city: Guangzhou
country: China
facility: Guangzhou Army General Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hong Kong
country: China
facility: United Christian Hospital
city: Shanghai
country: China
facility: Shanghai Renji Hospital (East)
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Avignon Cedex 9
country: France
facility: Hôpital Henri Duffaut
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Brest Cedex
country: France
facility: Hôpital de la Cavale Blanche
city: Dijon
country: France
facility: Hôpital du Bocage - CHU
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve - CHU
city: RENNES Cedex
country: France
facility: Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU
city: Rouen
country: France
facility: Hôpital Charles Nicolle
city: Bad Oeynhausen
country: Germany
facility: Kardiologische Klinik Herz- und Diabeteszentrum
city: Bad Segeberg
country: Germany
facility: Segebergerkliniken
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Dachau
country: Germany
facility: Amper Kliniken-Kreisklinik
city: Dresden
country: Germany
facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum, Medizinische Klinik III
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Villingen-Schwenningen
country: Germany
facility: Kliniken Villingen
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Hospital
city: Thessaloniki
country: Greece
facility: Cardiology Clinic of Papageorgiou Hospital
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Cardiovascular Surgery
city: Pécs
country: Hungary
facility: University of Pécs/Medical School/Heart Institute
city: Hyderabaad
country: India
facility: Apollo Hospital
state: Andhar Pradesh
city: Hyderabaad
country: India
facility: CARE Hospital
state: Andhra Pradesh
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
city: New Delhi
country: India
facility: Max Devki Devi Heart & Vascular Insititute, Department of Cardiology
city: New Delhi
country: India
facility: Escorts Heart Institute & Research Centre
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Milano
country: Italy
facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Modena
country: Italy
facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
city: Modena
country: Italy
facility: Hesperia Hospital
city: Palermo
country: Italy
facility: L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli
city: Perugia
country: Italy
facility: A.O Di Perugia, Ospedale Silvestrini
city: Pisa
country: Italy
facility: Ospedale Cisanello
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera Santa Maria Nuova
city: Rome
country: Italy
facility: A.O. Universitaria Tor Vergata, Cardiologia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: San Donato
country: Italy
facility: Instituto Policlinico S. Donato
city: Riga
country: Latvia
facility: Latvian Center of Cardiology, P. Stradina University Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malay Medical Center
state: Lembah Pantai
city: Amsterdam
country: Netherlands
facility: Het Onze Lieve Vrouwe Gasthuis (OLVG)
city: Amsterdam
country: Netherlands
facility: AMC
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Bergen
country: Norway
facility: Haukeland university hospital
city: Feiring
country: Norway
facility: Feiringklinikken AS
city: Ustroń
country: Poland
facility: Polsko Amerykanskie-Kliniki Serca American Heart
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Lisboa
country: Portugal
facility: Hospitalar Santa Marta
city: Porto
country: Portugal
facility: Hospital São João
city: Moscow
country: Russian Federation
facility: Bakulev Scientific Center for Cardiovascular Surgery
city: Bloemfontein
country: South Africa
facility: Bloemfontein Medi-Clinic
city: Pretoria
country: South Africa
facility: Unitas Hospital
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos, Hemodynamics Department
city: Zaragoza
country: Spain
facility: H. Miguel Servet. Zaragoza, Cardiology Service
city: Bern
country: Switzerland
facility: Inselspital Bern, Kardiologie
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Freeman Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
city: Caracas
country: Venezuela
facility: Centro Medico de Caracas
city: Caracas
country: Venezuela
facility: Clinica Santa Sofia
Study officials:
affiliation: Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
name: Marie-Claude Morice
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bern, Bern, Switzerland
name: Stephan Windecker
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.