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

Exclusion Criteria20

• 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)