EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
NCT01435031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2018-05-09
Summary
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions
Conditions
- Coronary Artery Disease (CAD)
- Chronic Total Occlusion (CTO)
Interventions
- DEVICE
-
CTO Treatment Device
Subjects receiving at least 1 of the following for the treatment of CTO: * XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent * HT PROGRESS and/or HT PILOT guide wires in recanalization * MINI-TREK Coronary Dilatation Catheter in predilatation
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
David E. Kandzari, MD · Piedmont Heart Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2014-02-28
- Completion
- 2017-12-31
Countries
- United States
Study Locations
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