Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

Thoracic Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164201
• Other study ID #: BFM1301.000-M
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: July 27, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: CryoLife Europa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionItaly: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Valve Replacement
• Cardiovascular Procedures
• Thoracic Aortic Aneurysm
• Type A Aortic Dissection

Locations

Country	Name	City	State
Germany	German Heart Center	Munich
Italy	San Raffale Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife Europa

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of haemostasis		3 minutes after application	No
Secondary	Time to haemostasis		measured through to 10 minutes	No