A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts

NCT02476318 | Completed

• 1 other identifier: CLN-008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Vascular Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative

Study Arms (1)

ArterX Vascular Sealant

EXPERIMENTAL

Device: ArterX Vascular Sealant

Interventions

ArterX Vascular Sealant DEVICE

ArterX Vascular Sealant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tenaxis Medical, Inc.: lead

Study Sites (3)

Klinikum der Universitat zu Koln

Cologne, Germany

Location

Krankenhaus Dresden Friedrichstadt

Dresden, Germany

Location

Chirugische Uni Klinikum

Ulm, Germany

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Hans J Florek, MD

  Krankenhaus Dresden Friedrichstadt Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 19, 2015
• Study Start: June 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

DE (3)