The Evicel Post-Authorization Surveillance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158261
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Peripheral Vascular Disease Hemorrhage Biological: EVICEL ™ Fibrin Sealant (Human)

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
Study Start Date : June 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Group/Cohort Intervention/treatment
Vascular Surgery Subjects Treated with EVICEL Biological: EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Other Name: Fibrin Sealant (Human)

Primary Outcome Measures :
  1. Specific Safety Parameters [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects requiring elective vascular procedures

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158261

United States, Florida
Baptist Health Medical Center
Jacksonville, Florida, United States, 32207
Memorial Hospital
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Ethicon, Inc.
OMRIX Biopharmaceuticals
Study Director: Richard Kocharian, MD Ethicon, Inc.

Responsible Party: Ethicon, Inc. Identifier: NCT01158261     History of Changes
Other Study ID Numbers: 400-08-004
First Posted: July 8, 2010    Key Record Dates
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015
Last Verified: July 2015

Keywords provided by Ethicon, Inc.:

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases
Fibrin Tissue Adhesive