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Clinical Trial Summary

The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)] at 6 weeks post implantation.

Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks post-implantation.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Drug Eluting Stents (DES)
  • Optical Coherence Tomography (OCT)
  • Percutaneous Coronary Intervention (PCI)
  • Uncovered and Malapposed Stent Struts

NCT number NCT01962740
Study type Interventional
Source North Texas Veterans Healthcare System
Contact
Status Terminated
Phase N/A
Start date September 2013
Completion date March 2015

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