The Evicel Post-Authorization Surveillance Study
Completed
Conditions studied: Peripheral Vascular Disease, Hemorrhage
In brief
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 vascular surgery.
Key facts
- Study ID
- NCT01158261
- Run by
- Ethicon, Inc.
- People needed
- 300
- Starts
- 2010-06-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2015-08-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Baptist Health Medical Center — Jacksonville, Florida, United States
- Memorial Hospital — Jacksonville, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.