SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Completed · Phase 3

Conditions studied: Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis

In brief

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.

Key facts

Study ID

NCT00180479

Run by

Abbott Medical Devices

People needed

1002

Starts

2005-06-01

Expected to finish

2011-11-01

Last updated by the study team

2011-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
• The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
• Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)

You may not qualify if…

• Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
• Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
• Located in a major epicardial vessel that has been previously treated with brachytherapy
• Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
• Total occlusion (TIMI flow 0), prior to wire passing
• The target vessel contains thrombus
• Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion

Where it is running

• Baptist Health System - Montclair — Birmingham, Alabama, United States
• Arizona Heart Hospital — Phoenix, Arizona, United States
• Scripps Memorial Hospital — La Jolla, California, United States
• Good Samaritan Hospital — Los Angeles, California, United States
• Alta Bates Summit Medical Center — Oakland, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Holy Cross Medical Center (prev. North Ridge MC) — Fort Lauderdale, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Emory Crawford Long Hospital — Atlanta, Georgia, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Saint Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Elmhurst Memorial Hospital — Elmhurst, Illinois, United States
• St. John's Hospital — Springfield, Illinois, United States
• The Heart Center of IN, LLC — Indianapolis, Indiana, United States
• Jewish Hospital — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• St. Joseph Medical Center — Towson, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baptist Medical Center Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.