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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,600
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Hosital Italiano de Buenos Aires - Cardiologia
Buenos Aires, Buenos Aires, Argentina
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, Argentina
The Northern Hospital
Epping, Australia
Liverpool Hospital
New South Wales, Australia
Landesklinikum St. Pölten
Sankt Pölten, Austria
Adjudicated Composite rate of all Death, all Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
Time frame: at 1 year
Acute Success (Clinical Device Success and Clinical Procedure Success)
Time frame: Acute
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: at 30 days
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time frame: at 30 days
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time frame: at 30 days
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time frame: at 30 days
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time frame: at 30 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 30 days
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: at 240 Days
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: at 1 Year
Adjudicated Stent Thrombosis (Definite, Probable, Possible)
Time frame: at 2 Years
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time frame: at 240 Days
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time frame: at 1 year
Adjudicated revascularization (TLR/TVR/all revascularizations)
Time frame: at 2 years
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time frame: at 240 Days
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time frame: at 1 Year
Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR.
Time frame: at 2 Years
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time frame: at 240 Days
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time frame: at 1 Year
Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR).
Time frame: at 2 Years
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time frame: at 240 Days
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time frame: at 1 Year
Adjudicated Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR.
Time frame: at 2 years
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 240 Days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 1 year
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).
Time frame: at 2 Years
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Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
Vienna, Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
CHU Charleroi
Charleroi, Belgium
Heilig Hart Ziekenhuis Roeselare
Roeselare, Belgium
...and 85 more locations