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

August 16, 2016 updated by: Cristina Giglioli, MD, Azienda Ospedaliero-Universitaria Careggi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CRE8 stent
Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months
Device: optical coherence tomography at 6 months
6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography
ACTIVE_COMPARATOR: Biomatrix stent
Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months
Device: optical coherence tomography at 6 months
6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography
ACTIVE_COMPARATOR: patients treated with Xience stent
Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months
Device: optical coherence tomography at 6 months
6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stent struts coverage assessed by means of intracoronary optical coherence tomography
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)
Time Frame: 12 months
12 months
inducible ischemia at myocardial scintigraphy
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Investigators

  • Principal Investigator: Cristina Giglioli, MD, Azienda Ospedaliero-Universitaria Careggi, Florence, ITALY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 875/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To date a decision has not been taken with regard to a possible plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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