Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/2/2016 |
| Start Date: | September 2013 |
| Contact: | Shuaib Abdullah, MD |
| Email: | Shuaib.Abdullah@va.gov |
| Phone: | 214-8571458 |
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.
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.
Inclusion Criteria:
1. Age greater than or equal to 18 years
2. Clinical need for percutaneous coronary intervention using either a Xience, Promus
Element, or Resolute Integrity drug-eluting stent using optical coherence tomography
optimization
3. Native coronary artery de novo lesion with ≥70% angiographic percent diameter
stenosis by visual estimation
4. Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
5. Target lesion ≤28 mm in length by visual estimate
6. Agree to participate and provide informed consent
Exclusion Criteria:
1.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)
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