SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System
NCT00180453 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2010-01-06
Summary
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial.
Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK VISION® metallic stent(stent length: 18mm, diameter: 3.0mm) Follow-up angiographic imaging and intra vascular ultra sound (IVUS) at 180 days and 1 year
Conditions
- Coronary Artery Disease
- Everolimus
- Vascular Disease
- Myocardial Ischemia
- Coronary Artery Stenosis
Interventions
- DEVICE
-
Coronary artery drug eluting stent placement
Coronary artery drug eluting stent placement
- DEVICE
-
Coronary artery stent placement
Coronary artery stent placement
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Patrick Serruys, MD · Erasmus Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2005-04-30
- Completion
- 2009-06-30
Countries
- Denmark
- Germany
- Netherlands
Study Locations
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