CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 455 enrolled
Drug / intervention
XIENCE V®/ XIENCE PRIME™ +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01182428
NCT01182428Phase 4Completed
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A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

Abbott Medical Devices·interventional·Posted Aug 16, 2010·Updated Aug 7, 2012

In Brief

A Phase 4 clinical trial evaluating XIENCE V®/ XIENCE PRIME™ and CYPHER SELECT for Coronary Artery Stenosis and 7 related conditions. Completed, enrolled 455 participants across 25 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis, Total Coronary Occlusion, Stent Thrombosis, Vascular Disease, Myocardial Ischemia
CountriesArgentina, Austria, Belgium, Brazil, Denmark, France, Germany, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Spain, Switzerland
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2010
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.9 years ago

Interventions

XIENCE V®/ XIENCE PRIME™device

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

CYPHER SELECTdevice

XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions