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Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)

NCT01962740 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-06-29

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Drug-eluting stent implantation

Sponsors & Collaborators

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Shuaib Abdullah, MD · North Texas Veterans Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01962740 on ClinicalTrials.gov