XIENCE V: SPIRIT WOMEN Sub-study

Phase 4

Completed

Conditions: Coronary Artery Stenosis
Coronary Arteriosclerosis
Coronary Artery Disease
Coronary Artery Restenosis
Total Coronary Occlusion
Stent Thrombosis
Vascular Disease
Myocardial Ischemia

Interventions: Device: CYPHER SELECT
Device: XIENCE V®/ XIENCE PRIME™

Registration Number: NCT01182428

Lead Sponsor: Abbott Medical Devices

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 455

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYPHER SELECT	CYPHER SELECT	-
XIENCE V® / XIENCE PRIME™	XIENCE V®/ XIENCE PRIME™	-

Primary Outcome Measures

Name	Time	Method
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	at 1 year	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.
In-stent Late Loss (LL) (Main Secondary Endpoint)	at 270 days	In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.

Secondary Outcome Measures

Name	Time	Method
Clinical Device Success	Intra-operative	Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.
Clinical Procedure Success	Intra-operative	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.
Adjudicated Stent Thrombosis (Definite, Probable)	30 days to 1 year (Late)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)	30 days to 1 year (Late)
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).	at 30 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.	at 1 year
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).	at 1 year
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).	at 1 year
In-segment Late Loss (LL)	at 270 days	LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up
In-stent Angiographic Binary Restenosis Rates	at 270 days	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).
In-segment Angiographic Binary Restenosis Rates	at 270 days	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).
In-stent Percent Diameter Stenosis	at 270 days
In-segment Percent Diameter Stenosis	at 270 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	at 1 year	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations
Aneurysm	at 270 days	All subjects with aneurysm of the target lesion up to the 270 day follow-up visit
Thrombus	at 270 days	All subjects with thrombus of the target lesion up to the 270 day follow-up visit
Persisting Dissection	at 270 days	All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit

Trial Locations

Locations (25): Institute of Cardiology
🇵🇱
Warsaw, Poland
Ospedale Cisanello
🇮🇹
Pisa, Italy
Kardiologische Klinik Herz- und Diabeteszentrum
🇩🇪
Bad Oeynhausen, Germany
Heilig Hart Ziekenhuis Roeselare
🇧🇪
Roeselare, Belgium
Hospital General de Alicante
🇪🇸
Alicante, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸
Barcelona, Spain
Hosital Italiano de Buenos Aires - Cardiologia
🇦🇷
Buenos Aires, Argentina
Inselspital Bern, Kardiologie
🇨🇭
Bern, Switzerland
Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
🇮🇹
Milano, Italy
Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
🇮🇹
Modena, Italy
Istituto Clinico Humanitas
🇮🇹
Rozzano, Italy
Instituto Cardiovascular de Buenos Aires-ICBA
🇦🇷
Buenos Aires, Argentina
Segebergerkliniken
🇩🇪
Bad Segeberg, Germany
Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
🇦🇹
Wien, Austria
Technische Universität Dresden, Medizinische Klinik II - Kardiologie
🇩🇪
Dresden, Germany
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
🇧🇷
Sao Paulo, Brazil
Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
🇫🇷
Massy, France
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
AMC
🇳🇱
Amsterdam, Netherlands
Cardiocentro Ticino
🇨🇭
Lugano, Switzerland
Latvian Center of Cardiology, P. Stradina University Hospital
🇱🇻
Riga, Latvia
Rigshospitalet
🇩🇰
Copenhagen, Denmark
Centro Cardiologico Monzino
🇮🇹
Milan, Italy
Semmelweis University, Department of Cardiovascular Surgery
🇭🇺
Budapest, Hungary
Haukeland university hospital
🇳🇴
Bergen, Norway