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

Veterans Affairs (VA) North Texas Health Care System

Status: Terminated

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

Treatments: Device: Drug-eluting stent implantation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01962740

13-043

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Xience EES

Active Comparator group

Description:

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

Treatment:

Device: Drug-eluting stent implantation

Resolute Integrity ZES

Active Comparator group

Description:

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

Treatment:

Device: Drug-eluting stent implantation

Promus Element EES

Active Comparator group

Description:

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

Treatment:

Device: Drug-eluting stent implantation