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

Study Overview
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Brief Summary
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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.

Official Title
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Serial Evaluation of Drug-Eluting Stents Using OCT

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

Intervention / Treatment
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* Device: Drug-eluting stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xience EES<br>This arm of patients will receive Xience Everolimus Eluting Stents(EES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging | Device: Drug-eluting stent implantation<br> <br> |
| Active Comparator: Resolute Integrity ZES<br>This arm of patients will receive Resolute Integrity Zotaralimus Eluting Stents (ZES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging | Device: Drug-eluting stent implantation<br> <br> |
| Active Comparator: Promus Element EES<br>This arm of patients will receive Promus Element Everolimus Eluting Stents (EES) as part of their clinically indicated PCI procedure and they will undergo Optical Coherence Tomography Imaging | Device: Drug-eluting stent implantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Strut Coverage |  | 6 weeks post-implantation | 
| Stent Strut Malapposition |  | 6 weeks post-implantation |