CompletedNCT00759681StEPSUpdated Jan 31, 2013Results posted

ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

A Phase 3 interventional study of ArterX Surgical Sealant and Gelfoam and Thrombin in Vascular Disease, sponsored by Tenaxis Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-31.

Sponsored by Tenaxis Medical, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 217
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.

Read the detailed description

To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.

Conditions studied

Vascular Disease

Browse trials for

Vascular Diseases 1,027

Keywords

Arterial Surgery
Open vascular Surgery
Sealant

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 217 is above the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Tenaxis Medical, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject must meet all of the following criteria to be eligible for treatment in the Study:

The subject must be equal or greater than 18 years old.
The subject must be scheduled for the surgical placement of a synthetic (i.e., PTFE/Dacron) vascular graft or patch for large vessel repair/arterial reconstruction/hemodialysis access/arteriotomy.
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 the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
The subject or guardian must provide written informed consent using a form that is reviewed and approved by the IRB.

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded from the Study if any of the following criteria are met:

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 transfusions.
The subject is currently enrolled in this, or another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. Note: Extended follow-up trials for products that were investigational but are currently commercially available are not considered investigational trials.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 217 participants (actual)

Study arms

Active comparator
Control
Gelfoam and Thrombin
Device: Gelfoam and Thrombin
Experimental
Investigational Device
ArterX Surgical Sealant
Device: ArterX Surgical Sealant

Interventions

DeviceArterX Surgical Sealant
Apply at the suture site.
Also known as: ArterX Vascular Sealant
DeviceGelfoam and Thrombin
Apply at the suture site.
Also known as: Gelfoam Plus

What researchers measure

Primary outcomes

Immediate Sealing Evidenced by no Bleeding on Clamp Release.
The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery
Time frame: Immediate at time of surgery
Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response
The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.
Time frame: Treatment through 6 weeks

Results

Posted Jan 31, 2013

Limitations and caveats

There were no significant trial limitations.

Participant flow

A total of 217 subjects (110 ArterX, 107 Control) were treated at eleven (11) participating investigational centers. Randomized subjects were treated from 10/08 to 12/09. The last follow-up visit was conducted in 03/10.

Participant flow — Overall Study
Milestone	Control: Gelfoam and Thrombin	Investigational Device: ArterX Surgical Sealant
Started	107	110
Completed	97	100
Not completed	10	10
Withdrew: Death	2	5
Withdrew: Lost to follow-up	8	5

Outcome measures

PrimaryImmediate Sealing Evidenced by no Bleeding on Clamp Release.

The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery

Time frame:: Immediate at time of surgery
Reported as:: Number · Treatment sites

Immediate Sealing Evidenced by no Bleeding on Clamp Release.
Treatment sites	Control Treatment	Investigational Device
Immediate Sealing Evidenced by no Bleeding on Clamp Release.	65	101

Statistical analysis

Control Treatment vs Investigational Device · Exact binomial confidence limit · p = 0.05 · Mean difference (final values): 0.208 · 95% CI 0.103 to 0.314Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.

PrimaryCumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response

The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.

Time frame:: Treatment through 6 weeks
Reported as:: Number · participants

Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response
participants	Control Treatment	Investigational Device
Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response	64	51

Statistical analysis

Control Treatment vs Investigational Device · Exact binomial confidence limit · p = 0.05 · Mean difference (final values): -0.135The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.

Adverse events

Collected over Adverse events were collected through 3 months post surgery.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
2. Gelfoam and Thrombin	—	26/107 (24.3%)	11/106 (10.4%)
1. ArterX Surgical Sealant	—	28/110 (25.5%)	9/108 (8.3%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	2. Gelfoam and Thrombin	1. ArterX Surgical Sealant
InfectionInfections and infestations	19/106	9/108
DeathInvestigations	2/107	5/110
Neurological DeficitNervous system disorders	2/105	3/108
Significant BleedingSurgical and medical procedures	2/107	3/110
HypotensionVascular disorders	0/107	3/110
Thrombosis/ThromboembolismVascular disorders	1/107	3/110
Respiratory Failure/DysfunctionRespiratory, thoracic and mediastinal disorders	2/107	3/110
IschemiaVascular disorders	1/107	2/110
Steal SyndromeVascular disorders	0/107	2/110
Pleural EffusionRespiratory, thoracic and mediastinal disorders	1/107	0/110

Most frequent other events

Most frequent other events
Event	2. Gelfoam and Thrombin	1. ArterX Surgical Sealant
Non-serious InfectionsInfections and infestations	11/106	9/108

Baseline characteristics

Age Continuous
Age Continuous(years)	Control	Investigational Device	Total
Mean	65.7 ± 12.3	66.2 ± 12.3	66.0 ± 12.3

Sex: Female, Male
Sex: Female, Male(Participants)	Control	Investigational Device	Total
Female	37	41	78
Male	70	69	139

Region of Enrollment
Region of Enrollment(participants)	Control	Investigational Device	Total
United States	107	110	217

Study locations

1 site

Greenville Memorial Hospital
Greenville, South Carolina 29615, United States

References and documents

Publications

Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012 Nov;26(8):1077-84. doi: 10.1016/j.avsg.2012.02.013. Epub 2012 Aug 29. PubMed 22939276 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00759681
Lead sponsor: Tenaxis Medical, Inc.
Responsible party: Sponsor
First posted: Sep 25, 2008
Start date: Sep 2008
Primary completion: Dec 2009
Completion: Mar 2010
Results posted: Jan 31, 2013
Last update: Jan 31, 2013

Study contacts

David Cull, MD

principal investigator · Greenville Hospital System

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vascular Diseases→

Other studies from this sponsor

Tenaxis Medical, Inc.

Start the discussion