ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.

Conditions
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Vascular Disease

Intervention / Treatment
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* Device: ArterX Surgical Sealant
* Device: Gelfoam and Thrombin


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Gelfoam and Thrombin | Device: Gelfoam and Thrombin<br>* Apply at the suture site.<br>* Other names: Gelfoam Plus;|
| Experimental: Investigational Device<br>ArterX Surgical Sealant | Device: ArterX Surgical Sealant<br>* Apply at the suture site.<br>* Other names: ArterX Vascular Sealant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Treatment through 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterial Surgery, Open vascular Surgery, Sealant