Study to Assess Safety and Effectiveness of the Rapidlink Device for Repairing or Replacing Supra-Aortic Vessels During Open Surgery on the Thoracic Aorta

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Rapidlink device in patients undergoing open surgical repair of the thoracic aorta involving the supra-aortic vessels, such as the left subclavian artery, left common carotid artery, and innominate artery. The study addresses challenges in repairing these vessels during surgery, aiming to simplify and speed up the process while reducing the need for additional procedures. This is an interventional study sponsored by Vascutek Ltd. focusing on patients with aortic disease requiring vessel repair or replacement. Participants will have the Rapidlink device implanted in one or more of the supra-aortic vessels during their planned or emergency open thoracic aorta surgery. The device consists of a graft section attached to a stented section, designed to be placed with minimal sutures and manipulation. The study first enrolls 32 patients undergoing left subclavian artery repair or replacement, then expands to include other supra-aortic vessel repairs. Up to 30 additional patients will be enrolled in an emergency setting after the initial group. Participants are evaluated before, during, and after surgery, with follow-up visits at discharge, 30 days, 3 months, 6 months, 12 months, and 24 months. Evaluations include safety and clinical success measures, occurrence of adverse events such as stroke or vessel rupture, device integrity, and need for secondary interventions. The primary outcome is the absence of major adverse events six months after the procedure. Data collection involves clinical assessments and monitoring to understand the devices performance and safety over two years.

A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta