The Evicel Post-Authorization Surveillance Study

Ethicon

Status: Completed

Conditions: Hemorrhage; Peripheral Vascular Disease

Treatments: Biological: EVICEL ™ Fibrin Sealant (Human)

Study type: Observational

Funder types: Industry

Identifiers

NCT01158261

400-08-004

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Vascular Surgery Subjects Treated with EVICEL

Treatment:

Biological: EVICEL ™ Fibrin Sealant (Human)