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

NCT01962740 | Terminated DMC

• 1 other identifier: 13-043
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Stent Strut Coverage

  6 weeks post-implantation

• Stent Strut Malapposition

  6 weeks post-implantation

Study Arms (3)

Xience EES

ACTIVE COMPARATOR

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

Resolute Integrity ZES

ACTIVE COMPARATOR

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

Promus Element EES

ACTIVE COMPARATOR

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

Interventions

Drug-eluting stent implantation DEVICE

Promus Element EES; Resolute Integrity ZES; Xience EES

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Study Officials

• Shuaib Abdullah, MD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist; Assistant Professor, Division of Cardiology, Internal Medicine, UT Southwestern Medical School

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 14, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)