Aortic AneurysmNCT02375542
Characterization of Aortic Tissue at Reoperation
An observational study of Aortic Aneurysm and Aortic Dissection, run by CryoLife Europa at 1 site in Italy.
Trial summary
This study will analyse factors contributing to cardiac re-operation to determine causative effects Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective, Single center, single arm study.
Who may be able to join
- Subjects undergoing an aortic re-operation
- Subject has had BioGlue used during previous aortic surgery
- Subject is willing and able to give written informed consent for participation
Who cannot join
- Subject with a history of vasculitis
- Subject with active infection (endocarditis)
- Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
- Subject with a history of auto immune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation
This study will analyse factors contributing to cardiac re-operation to determine causative effects
Read the detailed description
This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.
- Conditions
- Aortic Aneurysm, Aortic Dissection
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Reoperation | Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The microscopic evaluation of the presence of BioGlue on aortic tissue
Measured: "participants will be followed for the duration of their surgery, an expected average of 5 hours
Secondary outcomes (1)
Observation and characterization of BioGlue usage during the reoperation procedure
Measured: "participants will be followed for the duration of their surgery, an expected average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife Europa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davide Pacini, Dr, Principal investigator, Cardiac Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375542
- Sponsor's protocol ID
- BIO1301.001M
- Status last verified
- Jul 2018
- First submitted
- 19 Aug 2014
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation
- ClinicalTrials.gov ID
- NCT02375542
- Acronym / sponsor ID
- BIO1301.001M
- Conditions
- Aortic Aneurysm, Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CryoLife EuropaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 2 Mar 2015 (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.
This study will analyse factors contributing to cardiac re-operation to determine causative effects
Detailed description
This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Reoperation | – | –Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective, Single center, single arm study.
Key inclusion criteria (3 listed)
- Subjects undergoing an aortic re-operation
- Subject has had BioGlue used during previous aortic surgery
- Subject is willing and able to give written informed consent for participation
Key exclusion criteria (4 listed)
- Subject with a history of vasculitis
- Subject with active infection (endocarditis)
- Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
- Subject with a history of auto immune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The microscopic evaluation of the presence of BioGlue on aortic tissue
Time frame: "participants will be followed for the duration of their surgery, an expected average of 5 hours
1 secondary outcome
Observation and characterization of BioGlue usage during the reoperation procedure
Time frame: "participants will be followed for the duration of their surgery, an expected average of 5 hours
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 19 Jul 2018.
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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.
Davide Pacini, Dr principal investigator
Cardiac Surgeon
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 Aortic Aneurysm and Aortic Dissection, run by CryoLife Europa 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 3 inclusion and 4 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 19 Jul 2018. 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?
The microscopic evaluation of the presence of BioGlue on aortic tissue (time frame: "participants will be followed for the duration of their surgery, an expected average of 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2018.