ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-03-31

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.

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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.

Conditions

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Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Gelfoam and Thrombin

Group Type ACTIVE_COMPARATOR

Gelfoam and Thrombin

Intervention Type DEVICE

Apply at the suture site.

Investigational Device

ArterX Surgical Sealant

Group Type EXPERIMENTAL

ArterX Surgical Sealant

Intervention Type DEVICE

Apply at the suture site.

Interventions

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ArterX Surgical Sealant

Apply at the suture site.

Intervention Type DEVICE

Gelfoam and Thrombin

Apply at the suture site.

Intervention Type DEVICE

Other Intervention Names

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ArterX Vascular Sealant Gelfoam Plus

Eligibility Criteria

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Inclusion Criteria

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

1. The subject must be equal or greater than 18 years old.
2. 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.
3. The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
4. The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
5. 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:

1. The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
2. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
3. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No