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

ConditionsAortic Aneurysm Aortic Aneurysm Abdominal Valve Stenoses, Aortic Valve Regurgitation, Mitral Valve Regurgitation, Tricuspid Aneurysm of Ascending Aorta Aneurysm Abdominal Artery Diseases, Peripheral Ventricular Aneurysm Coronary Artery Disease Valve Aortic Regurgitation Aortic Aneurysms Arch Aortic Aneurysms Descending Aortic Aneurysms Thoracoabdominal

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorGrena Biomed Limited

About this trial

This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a prosthetic or biologic graft, patch, or allograft.

The effectiveness of the adhesive will be assessed after restoring blood flow.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Patient has a history of bleeding diathesis or coagulopathy.

Presence of active infection or contamination in the to be grafted area or the vicinity.

Known vasculitis in the to be grafted area.

Trial design

Treatments tested in this trial

Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.

Treatment groups

60 Participants

are divided into 1 treatment group

Sponsors and collaborators

Grena Biomed Limited

Lead sponsor

Archer Research

Collaborator

Source ClinicalTrials.gov