Seal-V Safety and Performance Study

Study Overview
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Brief Summary
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The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.

Official Title
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Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System

Conditions
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C.Surgical Procedure; Vascular (Peripheral)

Intervention / Treatment
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* Device: Seal-V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of >18 years of age Signed Informed Consent Patients requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following: Peripheral bypass surgeries, such as arterio-arterial bypasses [including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass] Arteriovenous (AV) dialysis access shunt in the upper or lower extremity Patients able and willing to complete all follow-up visits Exclusion Criteria: Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above Reoperation at the same treatment site Known sensitivity to device materials, such as indigo carmine dye or alginate Pregnant or lactating women Systemic infection Participation in another clinical trial or treatment with any investigational agent in past 30 days Congenital coagulation disorders (e.g., thrombocytopenia [<100,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease) Severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs) Prior radiation therapy to the operating field Intraoperative Exclusion Criteria: Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure Intraoperative change in planned surgical procedure that results in the patient no longer meeting preoperative inclusion and/or exclusion criteria Local infection at the operating field

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seal-V<br>A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels. | Device: Seal-V<br>* Seal-V is applied adjunctively to cover the suture lines.<br>* Other names: SEAlantis Vascular WP2(A);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTH, Time to Hemostasis | Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site | Perioperative; within 10 minutes after clamp release | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cessation of bleeding at a treatment site |  | Perioperative; within 10 minutes after clamp release | 
| Intraoperative blood loss | Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis | Perioperative | 
| Incidence of successful deployment of the Seal-V device |  | Perioperative |