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

This study has been terminated.
(Lack of eligible patients)
Sponsor:
Information provided by (Responsible Party):
Shuaib Abdullah, MD, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01962740
First received: October 8, 2013
Last updated: June 27, 2016
Last verified: June 2016
  Purpose

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 Intervention
Drug Eluting Stents (DES)
Percutaneous Coronary Intervention (PCI)
Uncovered and Malapposed Stent Struts
Optical Coherence Tomography (OCT)
Device: Drug-eluting stent implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Serial Evaluation of Drug-Eluting Stents Using OCT

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Stent Strut Coverage [ Time Frame: 6 weeks post-implantation ] [ Designated as safety issue: No ]
  • Stent Strut Malapposition [ Time Frame: 6 weeks post-implantation ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: September 2013
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: October 8, 2013
Last Updated: June 27, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 21, 2016