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

Serial Evaluation of Drug-Eluting Stents Using OCT

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01962740

Acronym

STRUT-OCT

Enrollment

Registered

2013-10-14

Start date

2013-09-30

Completion date

2015-03-31

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICEDrug-eluting stent implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

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)

Design outcomes

Primary

Measure	Time frame
Stent Strut Coverage	6 weeks post-implantation
Stent Strut Malapposition	6 weeks post-implantation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026