NCT02850497

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Angina After Coronary Stent Placement

Interventions

Type	Name	Description
DEVICE	optical coherence tomography at 6 months	6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-08-01
• Last updated: 2016-08-17