A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery

Ethicon, Inc.2 sites in 1 country300 target enrollmentJune 2010

ConditionsPeripheral Vascular Disease Hemorrhage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Vascular Disease
Sponsor: Ethicon, Inc.
Enrollment: 300
Locations: 2
Primary Endpoint: Specific Safety Parameters
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

May 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ethicon, Inc.

Responsible Party

Sponsor

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