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

Launched by VASCUTEK LTD. · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called Rapidlink, which is used during open-heart surgery to repair or replace certain blood vessels near the heart, specifically those connected to the aorta—the large artery that carries blood from the heart to the rest of the body. The goal is to see if the Rapidlink device is safe and works well when used in these surgeries for people with conditions affecting the thoracic aorta, such as aneurysms (weakened areas that can bulge or tear).

People who might be eligible for this study are adults who need open surgery to fix their thoracic aorta and whose blood vessels fall within specific size ranges. They must agree to participate and be able to follow the study’s requirements. The study will first include patients having surgery to repair or replace one specific artery (the left subclavian artery), and later expand to include repairs to other nearby arteries, both in planned and emergency surgeries. Participants can expect their doctors to collect information before, during, and after surgery, with follow-up visits up to two years later to check on their recovery and the device’s performance. It’s important to know that people with certain health issues—like active infections, severe kidney problems, or allergies to device materials—may not be able to join the study. This trial is not yet recruiting patients but aims to improve treatment options for those undergoing complex aortic surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Patient does not have a clear landing zone equal to the implantable stent length which is free from stenosis, calcification or thrombus.
• • Patient does not have a sealing zone free from tortuosity.
• • Patient has significant angulation (\>79° with an internal radius of less than 6mm) for the full implantable stent length
• • Patient cannot receive anticoagulation / antiplatelet therapy during or after the index procedure as per the protocol
• • Patient has uncontrolled hypercoagulation
• • Patient has a condition which may compromise or prevent the necessary imaging requirements
• • Patient has anatomic variants which would compromise circulation to the first branch off the target artery after placement of the Rapidlink device (unless planned and/or otherwise revascularized)
• • Patient is unfit for open surgical repair involving circulatory arrest per the study investigator
• • Patient has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin
• • Patient has a ruptured aorta
• • Patient has active endocarditis or an active infective disorder of the aorta
• • Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
• • Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study
• • Patient is female and is pregnant or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception during the course of the study.
• • Patient has an uncorrectable bleeding anomaly
• • Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg/dL)
• • Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated
• • Patient has a co-morbidity causing expected survival to be less than 1 year
• • Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure
• • Patient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)