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

NCT ID: NCT02850497

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Recurrent Angina After Coronary Stent Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CRE8 stent

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

Group Type: ACTIVE_COMPARATOR

optical coherence tomography at 6 months

Intervention Type: DEVICE

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

Biomatrix stent

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

Group Type: ACTIVE_COMPARATOR

optical coherence tomography at 6 months

Intervention Type: DEVICE

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

patients treated with Xience stent

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

Group Type: ACTIVE_COMPARATOR

optical coherence tomography at 6 months

Intervention Type: DEVICE

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

Interventions

optical coherence tomography at 6 months

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Cristina Giglioli, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Giglioli, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Careggi, Florence, Italy

References

Giglioli C, Formentini C, Romano SM, Cecchi E, Baldereschi GJ, Landi D, Chiostri M, Prati F, Marchionni N. Vulnerable struts with CRE8, Biomatrix and Xience stents assessed with OCT and their correlation with clinical variables at 6-month follow-up: the CREBX-OCT study. Int J Cardiovasc Imaging. 2020 Feb;36(2):217-230. doi: 10.1007/s10554-019-01719-1. Epub 2019 Oct 30.

Reference Type: DERIVED

PMID: 31667661 (View on PubMed)

Other Identifiers

875/13

Identifier Type: -

Identifier Source: org_study_id