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

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.

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)