Clinical trial NCT01182428: XIENCE V: SPIRIT WOMEN Sub-study
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: 2010-08-16
Enrollment: 455
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

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 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)

Primary outcomes:
measure: Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).
timeFrame: at 1 year
measure: In-stent Late Loss (LL) (Main Secondary Endpoint)
timeFrame: at 270 days
Secondary outcomes:
measure: Clinical Device Success
timeFrame: Intra-operative
measure: Clinical Procedure Success
timeFrame: Intra-operative
measure: Adjudicated Stent Thrombosis (Definite, Probable)
timeFrame: < 1 day (Acute)
measure: Adjudicated Stent Thrombosis (Definite, Probable)
timeFrame: 1 to 30 days (Sub-Acute)
measure: Adjudicated Stent Thrombosis (Definite, Probable)
timeFrame: 30 days to 1 year (Late)
measure: Adjudicated Stent Thrombosis (Definite, Probable, Possible)
timeFrame: 30 days to 1 year (Late)
measure: Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).
timeFrame: at 30 days
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 All Death, All MI and Target Vessel Revascularization (TVR).
timeFrame: at 30 days
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 All Revascularization (TLR/TVR/Non TVR).
timeFrame: at 30 days
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 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 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: In-segment Late Loss (LL)
timeFrame: at 270 days
measure: In-stent Angiographic Binary Restenosis Rates
timeFrame: at 270 days
measure: In-segment Angiographic Binary Restenosis Rates
timeFrame: at 270 days
measure: In-stent Percent Diameter Stenosis
timeFrame: at 270 days
measure: In-segment Percent Diameter Stenosis
timeFrame: at 270 days
measure: Adjudicated Revascularization (TLR/TVR/All Revascularizations)
timeFrame: at 30 days
measure: Adjudicated Revascularization (TLR/TVR/All Revascularizations)
timeFrame: at 240 days
measure: Adjudicated Revascularization (TLR/TVR/All Revascularizations)
timeFrame: at 1 year
measure: Aneurysm
timeFrame: at 270 days
measure: Thrombus
timeFrame: at 270 days
measure: Persisting Dissection
timeFrame: at 270 days
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: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis Roeselare
city: Sao Paulo
country: Brazil
facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
city: Bad Oeynhausen
country: Germany
facility: Kardiologische Klinik Herz- und Diabeteszentrum
city: Bad Segeberg
country: Germany
facility: Segebergerkliniken
city: Dresden
country: Germany
facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Cardiovascular Surgery
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: Pisa
country: Italy
facility: Ospedale Cisanello
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Riga
country: Latvia
facility: Latvian Center of Cardiology, P. Stradina University Hospital
city: Amsterdam
country: Netherlands
facility: AMC
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Bergen
country: Norway
facility: Haukeland university hospital
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Bern
country: Switzerland
facility: Inselspital Bern, Kardiologie
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
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: Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.