Recurrent Angina After Coronary Stent PlacementCREBX-OCTNCT02850497
6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting Stent
A study testing optical coherence tomography at 6 months in people with Recurrent Angina After Coronary Stent Placement, run by Azienda Ospedaliero-Universitaria Careggi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Recurrent Angina After Coronary Stent Placement
- What is being tested?
- optical coherence tomography at 6 months
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter > 2,5 mm
Who cannot join
- Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty
About this study
Official title: 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.
Read the 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.
- Being tested
- optical coherence tomography at 6 months
- Keywords
- optical coherence tomography, malapposition, endothelization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography at 6 monthsDevice
6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| CRE8 stent | Active comparator | Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months Receives: Device: optical coherence tomography at 6 months |
| Biomatrix stent | Active comparator | Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months Receives: Device: optical coherence tomography at 6 months |
| patients treated with Xience stent | Active comparator | Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months Receives: Device: optical coherence tomography at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent struts coverage assessed by means of intracoronary optical coherence tomography
Measured: 6 months
Secondary outcomes (2)
MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)
Measured: 12 months
inducible ischemia at myocardial scintigraphy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startAug 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Angina After Coronary Stent PlacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Giglioli, MD, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Cristina Giglioli, MD, Principal investigator, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850497
- Sponsor's protocol ID
- 875/13
- Acronym
- CREBX-OCT
- Status last verified
- Aug 2016
- First submitted
- 30 Apr 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: To date a decision has not been taken with regard to a possible plan to share data
Publications
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.
PubMed 31667661
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Endothelization and Malapposition of Three New Generation Drug Eluting Stent: CRE8, Biomatrix and Xience
- ClinicalTrials.gov ID
- NCT02850497
- Acronym / sponsor ID
- CREBX-OCT / 875/13
- Keywords
- optical coherence tomography, malapposition, endothelization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRE8 stent | Active comparator | Device: optical coherence tomography at 6 monthsTreatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months |
| Biomatrix stent | Active comparator | Device: optical coherence tomography at 6 monthsTreatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months |
| patients treated with Xience stent | Active comparator | Device: optical coherence tomography at 6 monthsTreatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter > 2,5 mm
Key exclusion criteria (1 listed)
- Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomography at 6 months6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography | Device | Biomatrix stent, CRE8 stent, patients treated with Xience stent |
Primary outcome
stent struts coverage assessed by means of intracoronary optical coherence tomography
Time frame: 6 months
2 secondary outcomes
MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)
Time frame: 12 months
inducible ischemia at myocardial scintigraphy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 31667661Giglioli 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.
- Individual participant dataSharing planned: Undecided. To date a decision has not been taken with regard to a possible plan to share data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Giglioli, MD principal investigator
Azienda Ospedaliero-Universitaria Careggi, Florence, Italy
Questions about this trial
What is this clinical trial studying?
A study testing optical coherence tomography at 6 months in people with Recurrent Angina After Coronary Stent Placement, run by Azienda Ospedaliero-Universitaria Careggi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent struts coverage assessed by means of intracoronary optical coherence tomography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02850497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.