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Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164201
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
CryoLife Europa

Brief 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.

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.


Condition or disease
Cardiovascular Procedures Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Achievement of haemostasis [ Time Frame: 3 minutes after application ]

Secondary Outcome Measures :
  1. Time to haemostasis [ Time Frame: measured through to 10 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • • 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;
    • 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164201


Locations
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Germany
German Heart Center
Munich, Germany
Italy
San Raffale Hospital
Milan, Italy
Sponsors and Collaborators
CryoLife Europa
Investigators
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Principal Investigator: Bernhard Voss, PD Dr Med Deutsches Herzzentrum Muenchen
Principal Investigator: Ottavio Alfieri, Professor San Raffale Hospital
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Responsible Party: CryoLife Europa
ClinicalTrials.gov Identifier: NCT02164201    
Other Study ID Numbers: BFM1301.000-M
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by CryoLife Europa:
Type A Aortic Dissection (where the use of BioFoam is limited to the anastomotic site)
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aneurysm, Dissecting
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases