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
|
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- No Results Posted
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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 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 |
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 |
- Stent Strut Coverage [ Time Frame: 6 weeks post-implantation ]
- Stent Strut Malapposition [ Time Frame: 6 weeks post-implantation ]

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

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
United States, Texas | |
VA North Texas Health Care System | |
Dallas, Texas, United States, 75216 |
Principal Investigator: | Shuaib Abdullah, MD | North Texas Veterans Healthcare System |
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 |