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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00496938
Other study ID # 07-377
Secondary ID
Status Completed
Phase Phase 4
First received July 3, 2007
Last updated May 12, 2015
Start date July 2007
Est. completion date July 2011

Study information

Verified date May 2015
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:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
XIENCE V®/ XIENCE PRIME™
Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System

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Sponsors (1)

Lead Sponsor Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  China,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Latvia,  Malaysia,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain,  Switzerland,  United Kingdom,  Venezuela, 

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 Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 1 year Yes
Secondary Acute Success (Clinical Device Success and Clinical Procedure Success) Acute Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable, Possible) at 30 days Yes
Secondary Adjudicated revascularization (TLR/TVR/all revascularizations) at 30 days Yes
Secondary Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and CI-TLR. at 30 days 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 all Revascularization (TLR/TVR/non TVR. 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 30 days Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable, Possible) at 240 Days Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable, Possible) at 1 Year Yes
Secondary Adjudicated Stent Thrombosis (Definite, Probable, Possible) at 2 Years Yes
Secondary Adjudicated revascularization (TLR/TVR/all revascularizations) at 240 Days Yes
Secondary Adjudicated revascularization (TLR/TVR/all revascularizations) at 1 year Yes
Secondary Adjudicated revascularization (TLR/TVR/all revascularizations) at 2 years 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 Cardiac Death, MI attributed to the target vessel and CI-TLR. at 2 Years 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 Target Vessel Revascularization (TVR). at 1 Year Yes
Secondary Adjudicated Composite rate of all Death, all MI and Target Vessel Revascularization (TVR). at 2 Years 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 Composite rate of all Death, all MI and all Revascularization (TLR/TVR/non TVR. at 2 years 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 Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI). at 2 Years Yes
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