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

Study Overview

• Status: Terminated
• Conditions: Optical Coherence Tomography (OCT); Percutaneous Coronary Intervention (PCI); Drug Eluting Stents (DES); Uncovered and Malapposed Stent Struts
• Intervention / Treatment: Device: Drug-eluting stent implantation

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xience EES; 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
Active Comparator: Resolute Integrity ZES; 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
Active Comparator: Promus Element EES; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: North Texas Veterans Healthcare System
• Investigators: Principal Investigator: Shuaib Abdullah, MD, North Texas Veterans Healthcare System

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 14, 2013

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 13-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO