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

A vizsgálat adatai

Ki végzi

Vascutek Ltd.

Azonosító

NCT07078383

A regiszteradat frissítve

2026. július 27.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta

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 subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery.

After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting.

Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.

Bevonási feltételek: 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.

Kizáró feltételek: Patient cannot receive anticoagulation / antiplatelet therapy during or after the index procedure as per the protocol; Patient is unfit for open surgical repair involving circulatory arrest per the study investigator; 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 has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated; 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 condition which may compromise or prevent the necessary imaging requirements; 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 has an uncorrectable bleeding anomaly; Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg/dL); 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 has uncontrolled hypercoagulation; 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 has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin; Patient has a ruptured aorta; 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 a co-morbidity causing expected survival to be less than 1 year; Patient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s).

ClinicalTrials.gov NCT07078383