We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01158261
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):

July 6, 2010
July 8, 2010
July 22, 2015
August 19, 2015
August 19, 2015
June 2010
April 2014   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01158261 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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
Not Provided
Not Provided
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 Treated with EVICEL
Intervention: Biological: EVICEL ™ Fibrin Sealant (Human)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Ethicon, Inc.
Ethicon, Inc.
OMRIX Biopharmaceuticals
Study Director: Richard Kocharian, MD Ethicon, Inc.
Ethicon, Inc.
July 2015