Cardiovascular ProceduresNCT02164201
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
An observational study of Cardiovascular Procedures and Thoracic Aortic Aneurysm, run by CryoLife Europa at 2 sites in 2 countries.
Trial summary
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2014to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac or cardiovascular procedures, including, but not limited to: Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection (where BioFoam is limited to the anastomotic site)
Who may be able to join
- Subject is undergoing an elective cardiac or cardiovascular procedure;
- Subject is willing and able to give prior written informed consent for investigation participation; and
- Subject is > 18 years of age.
- Intraoperative inclusion criteria include:
- Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).
Who cannot join
- • Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;
- Subject with active infection (either systemic or in the repair region);
- Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
- Subject diagnosed with a coagulation disorder;
- Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
- Subject whose life expectancy is less than that required for the prescribed follow-up duration;
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- Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
- Subject who is immunocompromised.
- Intraoperative exclusion criteria include:
- Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
- Conditions
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection
- Keywords
- Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)
- Medical subject headings
- Aortic Aneurysm, Thoracic
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of haemostasis
Measured: 3 minutes after application
Secondary outcomes (1)
Time to haemostasis
Measured: measured through to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ProceduresStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- CryoLife Europa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernhard Voss, PD Dr Med, Principal investigator, Deutsches Herzzentrum MuenchenOttavio Alfieri, Professor, Principal investigator, San Raffale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164201
- Sponsor's protocol ID
- BFM1301.000-M
- Status last verified
- Jul 2015
- First submitted
- 12 Jun 2014
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT02164201
- Acronym / sponsor ID
- BFM1301.000-M
- Conditions
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection
- Keywords
- Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- CryoLife EuropaIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Jun 2014 (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 is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac or cardiovascular procedures, including, but not limited to: Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection (where BioFoam is limited to the anastomotic site)
Key inclusion criteria (5 listed)
- Subject is undergoing an elective cardiac or cardiovascular procedure;
- Subject is willing and able to give prior written informed consent for investigation participation; and
- Subject is > 18 years of age.
- Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).
Key exclusion criteria (10 listed)
- • Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;
- Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).
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
Achievement of haemostasis
Time frame: 3 minutes after application
1 secondary outcome
Time to haemostasis
Time frame: measured through to 10 minutes
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 29 Jul 2015.
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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.
Bernhard Voss, PD Dr Med principal investigator
Deutsches Herzzentrum Muenchen
Ottavio Alfieri, Professor principal investigator
San Raffale Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Procedures and Thoracic Aortic Aneurysm, run by CryoLife Europa at 2 sites in 2 countries.
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 5 inclusion and 10 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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, 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?
Achievement of haemostasis (time frame: 3 minutes after application). 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 29 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.