Coronary Artery DiseaseREVEALNCT00799344
REVEAL Study: Vessel Healing After Angioplasty
An observational study of Coronary Artery Disease, run by CeloNova BioSciences, Inc. at 1 site in Italy.
Trial summary
To address early vessel healing and thrombus formation after deployment of three distinct groups of stents Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Catania Stent
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Dec 2009
- Phase
- Observational
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that have two significant short lesions
Who may be able to join
- Lesion length ≤ 20 mm
- Two significant short lesions
Who cannot join
- Life expectancy < 1 year
- Left ventricular ejection fraction (LVEF) <30%
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) Trial: Rationale, Objectives and Design
To address early vessel healing and thrombus formation after deployment of three distinct groups of stents
Read the detailed description
A prospective, randomized study providing new evidences on early vessel healing and thrombus development after stenting with different devices.
- Conditions
- Coronary Artery Disease
- Being tested
- Catania Stent
- Keywords
- Coronary Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catania StentDevice
coronary stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Stent | Catania Stent Receives: Device: Catania Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of "healed stent struts" at 28-32 days
Measured: 30 days
Secondary outcomes (1)
Measurement of neointimal growth on stent struts
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionDec 2009
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 Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeloNova BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Corrado Tamburino, MD, Principal investigator, Ferrarotto Hospital, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799344
- Sponsor's protocol ID
- 9 of Nov 24 2008
- Acronym
- REVEAL
- Status last verified
- Jan 2014
- First submitted
- 25 Nov 2008
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
La Manna A, Prati F, Capodanno D, Di Salvo M, Sanfilippo A, Barrano G, Monaco S, Tamburino C. Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient. J Cardiovasc Med (Hagerstown). 2011 May;12(5):328-33. doi: 10.2459/JCM.0b013e3283406428.
PubMed 20962664
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) Trial: Rationale, Objectives and Design
- ClinicalTrials.gov ID
- NCT00799344
- Acronym / sponsor ID
- REVEAL / 9 of Nov 24 2008
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- CeloNova BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Nov 2008 (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.
To address early vessel healing and thrombus formation after deployment of three distinct groups of stents
Detailed description
A prospective, randomized study providing new evidences on early vessel healing and thrombus development after stenting with different devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent | – | Device: Catania StentCatania Stent |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have two significant short lesions
Key inclusion criteria (2 listed)
- Lesion length ≤ 20 mm
- Two significant short lesions
Key exclusion criteria (3 listed)
- Life expectancy < 1 year
- Left ventricular ejection fraction (LVEF) <30%
- Chronic kidney disease
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 |
|---|---|---|
| Catania Stentcoronary stent implantation | Device | Stent |
Primary outcome
percentage of "healed stent struts" at 28-32 days
Time frame: 30 days
1 secondary outcome
Measurement of neointimal growth on stent struts
Time frame: 30 days
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 16 Jan 2014.
- Derived from this study: PubMed 20962664La Manna A, Prati F, Capodanno D, Di Salvo M, Sanfilippo A, Barrano G, Monaco S, Tamburino C. Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient. J Cardiovasc Med (Hagerstown). 2011 May;12(5):328-33. doi: 10.2459/JCM.0b013e3283406428.
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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.
Corrado Tamburino, MD principal investigator
Ferrarotto Hospital, University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by CeloNova BioSciences, Inc. at 1 site in Italy.
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 2 inclusion and 3 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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
percentage of "healed stent struts" at 28-32 days (time frame: 30 days). 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 NCT00799344, 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 16 Jan 2014.