Back to resultsA Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Primary Purpose
Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ArterX Vascular Sealant
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Disease
Eligibility Criteria
Inclusion Criteria:
- The subject must be ≥ 18 years old
- The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access.
- The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
- The subject is willing and able to be contacted for minimum of 6 weeks follow up.
- The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee.
Exclusion Criteria:
- The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
- The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion.
- The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period.
- ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.
Sites / Locations
- Krankenhaus Dresden Friedrichstadt
- Klinikum der Universitat zu Koln
- Chirugische Uni Klinikum
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ArterX Vascular Sealant
Arm Description
Outcomes
Primary Outcome Measures
Number of anastomoses with immediate sealing of the suture line
Immediate suture line sealing on clamp removal, as evidenced by a lack of clinically significant bleeding. A minimum of 50% of the anastomoses were expected to be sealed immediately.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02476318
Brief Title
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Official Title
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tenaxis Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective, multi-center study to evaluate the safety and performance outcomes of the ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis between native vessel and synthetic vascular grafts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ArterX Vascular Sealant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ArterX Vascular Sealant
Primary Outcome Measure Information:
Title
Number of anastomoses with immediate sealing of the suture line
Description
Immediate suture line sealing on clamp removal, as evidenced by a lack of clinically significant bleeding. A minimum of 50% of the anastomoses were expected to be sealed immediately.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must be ≥ 18 years old
The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access.
The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
The subject is willing and able to be contacted for minimum of 6 weeks follow up.
The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee.
Exclusion Criteria:
The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion.
The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period.
ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans J Florek, MD
Organizational Affiliation
Krankenhaus Dresden Friedrichstadt Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Dresden Friedrichstadt
City
Dresden
Country
Germany
Facility Name
Klinikum der Universitat zu Koln
City
Koln
Country
Germany
Facility Name
Chirugische Uni Klinikum
City
Ulm
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
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