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
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
|
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
|
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
|
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.
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.
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
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.