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

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ClinicalTrials.gov Identifier: NCT01962740
Recruitment Status : Terminated (Lack of eligible patients)
First Posted : October 14, 2013
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Shuaib Abdullah, MD, North Texas Veterans Healthcare System

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Stent Strut Coverage [ Time Frame: 6 weeks post-implantation ]
  2. Stent Strut Malapposition [ Time Frame: 6 weeks post-implantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962740


Locations
United States, Texas
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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     History of Changes
Other Study ID Numbers: 13-043
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No