Phase 4
Completed N=455
XIENCE V: SPIRIT WOMEN Sub-study
Coronary Artery Stenosis · Coronary Arteriosclerosis · Coronary Artery Disease · Coronary Artery Restenosis
Source: ClinicalTrials.gov NCT01182428 ↗
Enrolled (actual)
455
Serious AEs
39.8%
Results posted
Jul 2012
Primary outcomePrimary: Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). — 21.5; 22 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |
15.33; 15.23 | — |
| PRIMARY In-stent Late Loss (LL) (Main Secondary Endpoint) |
0.20; 0.12 | — |
| SECONDARY Clinical Device Success |
91.1; 93.5 | — |
| SECONDARY Clinical Procedure Success |
85.2; 84.1 | — |
| SECONDARY Adjudicated Stent Thrombosis (Definite, Probable) |
0.0; 0.69 | — |
| SECONDARY Adjudicated Stent Thrombosis (Definite, Probable) |
0.0; 0.69 | — |
| SECONDARY Adjudicated Stent Thrombosis (Definite, Probable) |
0.0; 0.69 | — |
| SECONDARY Adjudicated Stent Thrombosis (Definite, Probable, Possible) |
0.35; 1.39 | — |
| SECONDARY Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR). |
11.51; 13.25 | — |
| SECONDARY Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. |
18.77; 18.67 | — |
| SECONDARY Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR. |
18.77; 18.67 | — |
| SECONDARY Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |
15.33; 15.23 | — |
| SECONDARY Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR). |
15.33; 15.23 | — |
| SECONDARY Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |
27.99; 30 | — |
| SECONDARY Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |
27.99; 30 | — |
| SECONDARY Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR). |
27.99; 30 | — |
| SECONDARY Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |
13.99; 15.33 | — |
| SECONDARY Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |
13.99; 15.33 | — |
| SECONDARY Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). |
13.99; 15.33 | — |
| SECONDARY In-segment Late Loss (LL) |
0.10; 0.04 | — |
| SECONDARY In-stent Angiographic Binary Restenosis Rates |
3.2; 0.7 | — |
| SECONDARY In-segment Angiographic Binary Restenosis Rates |
4.3; 2.1 | — |
| SECONDARY In-stent Percent Diameter Stenosis |
15.77; 13.62 | — |
| SECONDARY In-segment Percent Diameter Stenosis |
22.26; 20.14 | — |
| SECONDARY Adjudicated Revascularization (TLR/TVR/All Revascularizations) |
18.09; 19.33 | — |
| SECONDARY Adjudicated Revascularization (TLR/TVR/All Revascularizations) |
18.09; 19.33 | — |
| SECONDARY Adjudicated Revascularization (TLR/TVR/All Revascularizations) |
18.09; 19.33 | — |
| SECONDARY Aneurysm |
0.0; 0.0 | — |
| SECONDARY Thrombus |
0.3; 1.3 | — |
| SECONDARY Persisting Dissection |
0.0; 0.0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01182428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.