A Study to Evaluate the Safety and Performance of ArterX™... | NCT02476318

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

NCT02476318

Sponsor

Tenaxis Medical, Inc.

Status

Completed

Last Update Posted

Jun 19, 2015Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Vascular Disease

Interventions

ArterX Vascular Sealant

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Jun 16, 2015

First Submission Date that Met QC Criteria

Jun 16, 2015

First Posted Date

Jun 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2015

Last Update Posted Date

Jun 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Description	Intervention Names
ArterX Vascular Sealant	Experimental		Device: ArterX Vascular Sealant

Name	Type	Description	Arm Group Labels	Other Names
ArterX Vascular Sealant	Device		ArterX Vascular Sealant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans J Florek, MD	Krankenhaus Dresden Friedrichstadt Dresden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Universitat zu Koln		Cologne			Germany
Krankenhaus Dresden Friedrichstadt