N/A
Completed N=300
The Evicel Post-Authorization Surveillance Study
Source: ClinicalTrials.gov NCT01158261 ↗Enrolled (actual)
300
Serious AEs
7.3%
Results posted
Aug 2015
Primary outcomePrimary: Specific Safety Parameters — 12; 7; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specific Safety Parameters |
12; 7; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01158261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.