First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study

Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.

This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.

Inclusion Criteria:

• ≥18 years old;
• Surgical placement of an ePTFE patch for large carotid repair;
• Written informed consent given by the patient.

Exclusion Criteria:

• Known or suspected allergy or sensitivity to any test materials or reagents;
• Concomitant intake of immunosuppressive medications;
• Prior radiation therapy to the operating field;
• Previous surgical procedure performed on the same operating field;
• Current or recent (<3months) participation in another investigational study;
• Refusal to receive blood products;
• Pregnant or breast-feeding women