The Evicel Post-Authorization Surveillance Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2010 |
| End Date: | May 2014 |
A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
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.
is to observe the clinical safety performance of EVICEL when used as suture support for
haemostasis in vascular surgery.
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
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2
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