Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Evicel Post-Authorization Surveillance Study

This study has been completed.
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc. Identifier:
First received: July 6, 2010
Last updated: July 16, 2014
Last verified: July 2014

July 6, 2010
July 16, 2014
June 2010
April 2014   (final data collection date for primary outcome measure)
Specific safety parameters [ Time Frame: Up to 4-weeks post-operatively ] [ Designated as safety issue: Yes ]
  • Incidence of graft occlusion
  • Incidence of adverse events potentially related to non-graft thrombotic events
  • Incidence of bleeding events
Not Provided
Complete list of historical versions of study NCT01158261 on Archive Site
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The Evicel Post-Authorization Surveillance Study
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.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects requiring elective vascular procedures

  • Peripheral Vascular Disease
  • Hemorrhage
Biological: EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Other Name: Fibrin Sealant (Human)
Vascular Surgery Subjects
Intervention: Biological: EVICEL ™ Fibrin Sealant (Human)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
April 2014   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Ethicon, Inc.
Ethicon, Inc.
OMRIX Biopharmaceuticals
Study Director: Richard Kocharian, MD Ethicon, Inc.
Ethicon, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP