Percutaneous Coronary Intervention (PCI) Clinical Trial
— STRUT-OCTOfficial title:
Serial Evaluation of Drug-Eluting Stents Using OCT
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | March 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | VA North Texas Health Care System | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
North Texas Veterans Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stent Strut Coverage | 6 weeks post-implantation | No | |
Primary | Stent Strut Malapposition | 6 weeks post-implantation | Yes |
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