XIENCE V: SPIRIT WOMEN Sub-study

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: NCT01182428
• Other study ID #: 07-377 sub-study
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2010
• Last updated: July 23, 2012
• Start date: September 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• 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 Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.

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: 455
• Est. completion date: July 2011
• Est. primary completion date: February 2011
• 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 protocol-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: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), 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
• CYPHER SELECT
XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions

Locations

Country	Name	City	State
Argentina	Hosital Italiano de Buenos Aires - Cardiologia	Buenos Aires
Argentina	Instituto Cardiovascular de Buenos Aires-ICBA	Buenos Aires
Austria	Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II	Wien
Belgium	Heilig Hart Ziekenhuis Roeselare	Roeselare
Brazil	Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia	Sao Paulo
Denmark	Rigshospitalet	Copenhagen
France	Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud	Massy
Germany	Kardiologische Klinik Herz- und Diabeteszentrum	Bad Oeynhausen
Germany	Segebergerkliniken	Bad Segeberg
Germany	Technische Universität Dresden, Medizinische Klinik II - Kardiologie	Dresden
Hungary	Semmelweis University, Department of Cardiovascular Surgery	Budapest
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	Ospedale Cisanello	Pisa
Italy	Istituto Clinico Humanitas	Rozzano
Latvia	Latvian Center of Cardiology, P. Stradina University Hospital	Riga
Netherlands	AMC	Amsterdam
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Norway	Haukeland university hospital	Bergen
Poland	Institute of Cardiology	Warsaw
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Switzerland	Inselspital Bern, Kardiologie	Bern
Switzerland	Cardiocentro Ticino	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Denmark,  France,  Germany,  Hungary,  Italy,  Latvia,  Netherlands,  Norway,  Poland,  Spain,  Switzerland, 

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 MI and Target Vessel Revascularization (TVR).	This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.	at 1 year	Yes
Primary	In-stent Late Loss (LL) (Main Secondary Endpoint)	In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.	at 270 days	Yes
Secondary	Clinical Device Success	Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.	Intra-operative	Yes
Secondary	Clinical Procedure Success	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.	Intra-operative	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable)		< 1 day (Acute)	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable)		1 to 30 days (Sub-Acute)	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable)		30 days to 1 year (Late)	Yes
Secondary	Adjudicated Stent Thrombosis (Definite, Probable, Possible)		30 days to 1 year (Late)	Yes
Secondary	Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).		at 30 days	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 All Death, All MI and Target Vessel Revascularization (TVR).		at 30 days	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 All Revascularization (TLR/TVR/Non TVR).		at 30 days	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 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 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	In-segment Late Loss (LL)	LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up	at 270 days	Yes
Secondary	In-stent Angiographic Binary Restenosis Rates	Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of = 50% per quantitative coronary angiography (QCA).	at 270 days	Yes
Secondary	In-segment Angiographic Binary Restenosis Rates	Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of = 50% per quantitative coronary angiography (QCA).	at 270 days	Yes
Secondary	In-stent Percent Diameter Stenosis		at 270 days	Yes
Secondary	In-segment Percent Diameter Stenosis		at 270 days	Yes
Secondary	Adjudicated Revascularization (TLR/TVR/All Revascularizations)	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations	at 30 days	Yes
Secondary	Adjudicated Revascularization (TLR/TVR/All Revascularizations)	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations	at 240 days	Yes
Secondary	Adjudicated Revascularization (TLR/TVR/All Revascularizations)	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations	at 1 year	Yes
Secondary	Aneurysm	All subjects with aneurysm of the target lesion up to the 270 day follow-up visit	at 270 days	Yes
Secondary	Thrombus	All subjects with thrombus of the target lesion up to the 270 day follow-up visit	at 270 days	Yes
Secondary	Persisting Dissection	All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit	at 270 days	Yes