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

Percutaneous Coronary Intervention (PCI) Clinical Trial

— STRUT-OCT  

Official title:

Serial Evaluation of Drug-Eluting Stents Using OCT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01962740
• Other study ID #: 13-043
• Status: Terminated
• Phase: N/A
• First received: October 8, 2013
• Last updated: June 27, 2016
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: June 2016
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Drug Eluting Stents (DES)
• Optical Coherence Tomography (OCT)
• Percutaneous Coronary Intervention (PCI)
• Uncovered and Malapposed Stent Struts

Intervention

Device:
• Drug-eluting stent implantation

Locations

Country	Name	City	State
United States	VA North Texas Health Care System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

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