CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,002 enrolled
Drug / intervention
XIENCE V® Everolimus Eluting Coronary Stent +1 moredevice
Likely dose
XIENCE V® everolimus-eluting stent implantation (dose and duration not specified in trial record)AI-extracted
Key inclusion· 3
  • ✓Target lesion in native epicardial vessel with diameter 2.25–4.25 mm and length ≤32 mm
  • ✓Lesion in major artery or branch with ≥50% stenosis and <100% stenosis, TIMI flow ≥1
  • ✓Prior non-target vessel percutaneous intervention allowed if ≥90 days before index procedure
Key exclusion· 8
  • ✕Lesion in arterial or saphenous vein graft, or distal to diseased graft (>20% stenosis)
  • ✕Bifurcation lesion ≥2 mm diameter or ostial lesion >50% stenosed or side branch requiring predilatation
  • ✕Target vessel previously treated with brachytherapy
  • ✕Target vessel treated with percutaneous intervention <9 months prior to index procedure

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

Search/NCT00180479
NCT00180479Phase 3Completed
CompareCT.gov

SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

Abbott Medical Devices·interventional·Posted Sep 16, 2005·Updated Nov 23, 2011

In Brief

A Phase 3 clinical trial evaluating XIENCE V® Everolimus Eluting Coronary Stent and TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent for Stents and 7 related conditions. Completed, enrolled 1,002 participants across 65 sites.

Detailed Summary

This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System 2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS 3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS 4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS 5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJun 1, 2005
Primary CompletionDec 1, 2006
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.8 years ago

Interventions

XIENCE V® Everolimus Eluting Coronary Stentdevice

Drug eluting stent implantation stent in the treatment of coronary artery disease.

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stentdevice

Drug eluting stent implantation stent in the treatment of coronary artery disease.