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Serial Evaluation of Drug-Eluting Stents Using OCT
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.
Age
18 - 89 years
Sex
ALL
Healthy Volunteers
No
VA North Texas Health Care System
Dallas, Texas, United States
Start Date
September 1, 2013
Primary Completion Date
February 1, 2015
Completion Date
March 1, 2015
Last Updated
June 29, 2016
3
ACTUAL participants
Drug-eluting stent implantation
DEVICE
Lead Sponsor
North Texas Veterans Healthcare System
NCT06916520
NCT06788275
Data Source & Attribution
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