Trials / Terminated
TerminatedNCT01962740
Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
Serial Evaluation of Drug-Eluting Stents Using OCT
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- North Texas Veterans Healthcare System · Federal
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Drug Eluting Stents (DES)
- Percutaneous Coronary Intervention (PCI)
- Uncovered and Malapposed Stent Struts
- Optical Coherence Tomography (OCT)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug-eluting stent implantation |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2015-02-01
- Completion
- 2015-03-01
- First posted
- 2013-10-14
- Last updated
- 2016-06-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01962740. Inclusion in this directory is not an endorsement.