The Evicel Post-Authorization Surveillance Study
Completed
- Conditions
- Peripheral Vascular DiseaseHemorrhage
- Interventions
- Biological: EVICEL ™ Fibrin Sealant (Human)
- Registration Number
- NCT01158261
- Lead Sponsor
- Ethicon, Inc.
- 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 vascular surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vascular Surgery Subjects Treated with EVICEL EVICEL ™ Fibrin Sealant (Human) -
- Primary Outcome Measures
Name Time Method Specific Safety Parameters Up to 4-weeks post-operatively * Incidence of graft occlusion
* Incidence of adverse events potentially related to non-graft thrombotic events
* Incidence of bleeding events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Memorial Hospital
🇺🇸Jacksonville, Florida, United States
Baptist Health Medical Center
🇺🇸Jacksonville, Florida, United States