6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting Stent

6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Endothelization and Malapposition of Three New Generation Drug Eluting Stent: CRE8, Biomatrix and Xience

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02850497

Acronym

CREBX-OCT

Enrollment

Registered

2016-08-01

Start date

2013-08-31

Completion date

2016-04-30

Last updated

2016-08-17

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

Conditions

Recurrent Angina After Coronary Stent Placement

Keywords

optical coherence tomography, malapposition, endothelization

Brief summary

Aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience.

Detailed description

This is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical follow-up will be performed to evaluate MACE at 12 months follow-up.

Interventions

DEVICEoptical coherence tomography at 6 months

6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter \> 2,5 mm

Exclusion criteria

* Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty

Design outcomes

Primary

Measure	Time frame
stent struts coverage assessed by means of intracoronary optical coherence tomography	6 months

Secondary

Measure	Time frame
MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)	12 months
inducible ischemia at myocardial scintigraphy	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026