XIENCE V: SPIRIT WOMEN

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00496938
• Collaborator: (none)
• Enrollment: 1,600
• Locations: 95
• Arm: 1
• Duration (Months): 48
• Patients Per Site: 16.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Stenosis; Coronary Arteriosclerosis; Coronary Artery Disease; Coronary Artery Restenosis; Total Coronary Occlusion; Stent Thrombosis; Vascular Disease; Myocardial Ischemia	Device: XIENCE V®/ XIENCE PRIME™	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 1600 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2007
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

2. Adjudicated Stent Thrombosis (Definite, Probable, Possible) [at 30 days]

3. Adjudicated revascularization (TLR/TVR/all revascularizations) [at 30 days]

4. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [at 30 days]

5. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [at 30 days]

6. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [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). [at 30 days]

8. Adjudicated Stent Thrombosis (Definite, Probable, Possible) [at 240 Days]

9. Adjudicated Stent Thrombosis (Definite, Probable, Possible) [at 1 Year]

10. Adjudicated Stent Thrombosis (Definite, Probable, Possible) [at 2 Years]

11. Adjudicated revascularization (TLR/TVR/all revascularizations) [at 240 Days]

12. Adjudicated revascularization (TLR/TVR/all revascularizations) [at 1 year]

13. Adjudicated revascularization (TLR/TVR/all revascularizations) [at 2 years]

14. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [at 240 Days]

15. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [at 1 Year]

16. Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. [at 2 Years]

17. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [at 240 Days]

18. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [at 1 Year]

19. Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). [at 2 Years]

20. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [at 240 Days]

21. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [at 1 Year]

22. Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. [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). [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). [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). [at 2 Years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Marie-Claude Morice, Institut Cardiovasculaire Paris Sud (ICPS), Paris, France
• Principal Investigator: Stephan Windecker, University Hospital Bern, Bern, Switzerland

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00496938
• Other Study ID Numbers: 07-377
• First Posted: Jul 6, 2007
• Last Update Posted: May 13, 2015
• Last Verified: May 1, 2015

• Keywords provided by Abbott Medical Devices: Stents; Angioplasty; Total coronary occlusions; Coronary restenosis; Stent thrombosis; Everolimus
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Thrombosis; Vascular Diseases; Arteriosclerosis; Coronary Stenosis; Coronary Occlusion; Coronary Restenosis; Ischemia

Study Results

No Results Posted as of May 13, 2015