Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery

Korábbi kezelés

• Patient takes immune suppressive medication like prednisone resulting in weakening of the vessel wall.
• Patients who are currently enrolled in another clinical study, or have recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.

Más betegség

• Patient has a history of bleeding diathesis or coagulopathy.
• Presence of active infection or contamination in the to be grafted area or the vicinity.

Laborértékek

• Patient has a known hypersensitivity, contraindication, or allergic reaction to albumin or glutaraldehyde.

Életkor

• Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release, abstinence).

Egyéb

• Known vasculitis in the to be grafted area.
• Patient is refusing blood transfusion.
• Patient or legal representative is unable / unwilling to provide informed consent.
• Patient is unable to comply with the protocol or proposed follow-up visits.
• Female patient is pregnant, lactating, or planning pregnancy during the clinical investigation.

• Patient ≥ 18 years of age at study entry.
• Patient is scheduled for open procedures for surgical placement of a prosthetic or biologic graft (patch) or an allograft for cardiac and (cardio)vascular anastomosis repair. Emergency, transplantation and minimally invasive procedures are excluded. Patients receiving long-term anticoagulation, including antiplatelet agent, are included. Choice of graft is at the discretion of the surgeon.
• Patient is willing and able to be contacted for up to 3 months (± 14 days) follow-up.
• Patient or legal representative and investigator signed and dated the informed consent form prior to the index-procedure.