Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

NCT02164201 | Completed

• 1 other identifier: BFM1301.000-M
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 2

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.

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)

Outcome Measures

Primary Outcomes (1)

• Achievement of haemostasis

  3 minutes after application

Secondary Outcomes (1)

• Time to haemostasis

  measured through to 10 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).

Sponsors & Collaborators

• CryoLife Europa: lead

Study Sites (2)

German Heart Center

Munich, Germany

Location

San Raffale Hospital

Milan, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Bernhard Voss, PD Dr Med

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Ottavio Alfieri, Professor

  San Raffale Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 16, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

IT (1); DE (1)