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

Azienda Ospedaliero-Universitaria Careggi

Status: Completed

Conditions: Recurrent Angina After Coronary Stent Placement

Treatments: Device: optical coherence tomography at 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT02850497

875/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

CRE8 stent

Active Comparator group

Description:

Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months

Treatment:

Device: optical coherence tomography at 6 months

Biomatrix stent

Active Comparator group

Description:

Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months

Treatment:

Device: optical coherence tomography at 6 months

patients treated with Xience stent

Active Comparator group

Description:

Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months

Treatment:

Device: optical coherence tomography at 6 months