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

Not Applicable

Completed

• Conditions: Recurrent Angina After Coronary Stent Placement
• Interventions: Device: optical coherence tomography at 6 months

• Registration Number: NCT02850497
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-04-30
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted QC: 2016-07-29
• Status Verified: 2016-08
• Study First Posted: 2016-08-01
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRE8 stent	optical coherence tomography at 6 months	Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months
Biomatrix stent	optical coherence tomography at 6 months	Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months
patients treated with Xience stent	optical coherence tomography at 6 months	Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months

Primary Outcome Measures

Name	Time	Method
stent struts coverage assessed by means of intracoronary optical coherence tomography	6 months

Secondary Outcome Measures

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