C.Surgical Procedure; Vascular (Peripheral)
Conditions
Brief summary
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.
Interventions
DEVICESeal-V
Seal-V is applied adjunctively to cover the suture lines.
Sponsors
Sealantis Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TTH, Time to Hemostasis | Perioperative; within 10 minutes after clamp release | Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful cessation of bleeding at a treatment site | Perioperative; within 10 minutes after clamp release | — |
| Intraoperative blood loss | Perioperative | Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis |
| Incidence of successful deployment of the Seal-V device | Perioperative | — |
Countries
Israel
Outcome results
None listed