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Completed

NCT Number: NCT02850497

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

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.

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Key information

Conditions

Recurrent Angina After Coronary Stent Placement

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography at 6 months

Device

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

Primary outcomes

  1. stent struts coverage assessed by means of intracoronary optical coherence tomography

    Time frame: 6 months

Secondary outcomes

  1. MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)

    Time frame: 12 months

  2. inducible ischemia at myocardial scintigraphy

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

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

Acronym: CREBX-OCT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2016
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.