ClinicaliQ Trial Snapshot
- 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 — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT07078383.
- What is being tested: The Rapidlink device is being evaluated for safety and effectiveness as an aid in open surgical repair of thoracic aortic disease, specifically for managing supra-aortic vessels during aortic replacement or repair procedures.
- Patient eligibility overview: The study enrolls patients requiring open surgical intervention for thoracic aortic disease who need reconstruction of supra-aortic vessels, typically those with conditions such as aneurysm, dissection, or atherosclerotic disease affecting the thoracic aorta.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd…
Eligibility Snapshot
- : * Patient is aged 18 years or over on date of consent * Written informed consent (from patient or a legally authorized representative) to participate in study, documenting willingness and ability to comply with all study procedures and study visits (unless an exemption for emergency cases has been IRB / EC approved) * Patient's need for open surgical repair of the thoracic aorta using a Gelweave graft or a Thoraflex Hybrid device (AnteFlo or Plexus) in line with the applicable IFU * Anticipated need to use Rapidlink for the repair or replacement of the LSA, LCCA and/or IA during the open surgical repair * Patient has an 8-15 mm inner diameter (target SAV) * The diameters of the patient's target supra-aortic vessel(s), fall within the ranges specified in the IFU
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.