Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
Stopped early · Not applicable
Conditions studied: Drug Eluting Stents (DES), Percutaneous Coronary Intervention (PCI), Uncovered and Malapposed Stent Struts, Optical Coherence Tomography (OCT)
In brief
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.
Key facts
- Study ID
- NCT01962740
- Run by
- North Texas Veterans Healthcare System
- People needed
- 3
- Starts
- 2013-09-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-06-29
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than or equal to 18 years
- Clinical need for percutaneous coronary intervention using either a Xience, Promus Element, or Resolute Integrity drug-eluting stent using optical coherence tomography optimization
- Native coronary artery de novo lesion with ≥70% angiographic percent diameter stenosis by visual estimation
- Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
- Target lesion ≤28 mm in length by visual estimate
- Agree to participate and provide informed consent
You may not qualify if…
- Presentation with acute ST-elevation myocardial infarction (defined as electrocardiographic (ECG) ST-elevation ≥ 2 mm in 2 or more contiguous ECG leads along with symptoms compatible with ischemia)
Where it is running
- VA North Texas Health Care System — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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