Status:
COMPLETED
The Evicel Post-Authorization Surveillance Study
Lead Sponsor:
Ethicon, Inc.
Collaborating Sponsors:
OMRIX Biopharmaceuticals
Conditions:
Peripheral Vascular Disease
Hemorrhage
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vasc...
Eligibility Criteria
Inclusion
- Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
- EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
- Subjects must be willing to and capable of participating in the study, and provide written informed consent
Exclusion
- Subjects with known intolerance to blood products
- Subjects unwilling to receive blood products
- Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
- Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01158261
Start Date
June 1 2010
End Date
May 1 2014
Last Update
August 19 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Baptist Health Medical Center
Jacksonville, Florida, United States, 32207
2
Memorial Hospital
Jacksonville, Florida, United States, 32216