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

Sponsor

North Texas Veterans Healthcare System (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT01962740

Collaborator

(none)

Enrollment

Location

Arms

17.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Eluting Stents (DES) Percutaneous Coronary Intervention (PCI) Uncovered and Malapposed Stent Struts Optical Coherence Tomography (OCT)	Device: Drug-eluting stent implantation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Serial Evaluation of Drug-Eluting Stents Using OCT

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Stent Strut Coverage [6 weeks post-implantation]
Stent Strut Malapposition [6 weeks post-implantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA North Texas Health Care System	Dallas	Texas	United States	75216

Sponsors and Collaborators

North Texas Veterans Healthcare System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shuaib Abdullah, MD, Cardiologist; Assistant Professor, Division of Cardiology, Internal Medicine, UT Southwestern Medical School, North Texas Veterans Healthcare System

ClinicalTrials.gov Identifier:

NCT01962740

Other Study ID Numbers:

13-043

First Posted:

Oct 14, 2013

Last Update Posted:

Jun 29, 2016

Last Verified:

Jun 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Jun 29, 2016