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The Evicel Post-Authorization Surveillance Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158261
First Posted: July 8, 2010
Last Update Posted: August 19, 2015
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.
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.
  Purpose
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 Intervention
Peripheral Vascular Disease Hemorrhage Biological: EVICEL ™ Fibrin Sealant (Human)

Study Type: Observational
Study Design: 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

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • 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


Enrollment: 300
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vascular Surgery Subjects Treated with EVICEL Biological: EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Other Name: Fibrin Sealant (Human)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects requiring elective vascular procedures
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01158261


Locations
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
Investigators
Study Director: Richard Kocharian, MD Ethicon, Inc.
  More Information

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01158261     History of Changes
Other Study ID Numbers: 400-08-004
First Submitted: July 6, 2010
First Posted: July 8, 2010
Results First Submitted: July 22, 2015
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015
Last Verified: July 2015

Keywords provided by Ethicon, Inc.:
hemostasis

Additional relevant MeSH terms:
Hemorrhage
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants