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

N/ATerminatedNCT01962740

North Texas Veterans Healthcare System3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Stent Strut Coverage

Time frame: 6 weeks post-implantation

Stent Strut Malapposition