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 (RAPID)

Vascutek

Status

Enrolling

Conditions

Aorta, Thoracic Pathologies

Aortic Aneurysm

Aortic Diseases

Aneurysmal Disease

Aneurysm of Aorta, Thoracic

Aortic Aneurysm and Dissection

Treatments

Device: Rapidlink

Study type

Interventional

Funder types

Industry

Identifiers

NCT07078383

RAPID-001

Details and patient eligibility

About

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.

Full description

Treatment options for pathologies involving the aortic arch include medical management, open surgical repair with vascular grafts (e.g., Gelweave), and frozen elephant trunk procedures (e.g., Thoraflex Hybrid).

During conventional replacement of the aortic arch, branches from the main graft are anastomosed onto the transected main arch vessels. In some circumstances this can be difficult for the surgeon, particularly in the case of the left subclavian artery which can be deep routed and difficult to access due to patient anatomy. It can also be displaced by aneurysmal disease or be fragile and friable secondary to atherosclerotic change.

An unmet need exists regarding the ability to access the supra-aortic vessels (e.g., left subclavian artery) in a timely manner during open surgical repair and to expedite the anastomosis to the arch while reducing the need to perform additional concomitant procedures (e.g., transposition or bypass of the left subclavian artery).

The Rapidlink device is designed to simplify this process by enabling the surgeon to place a stented graft within the supra-aortic vessels and secure it, with minimal sutures and manipulation, in a timely manner during open surgical repair.

This study will evaluate patients necessitating repair or replacement of the supra-aortic vessels (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) during open surgical repair of aortic disease affecting the thoracic aorta in an elective (Primary Arm) or emergent (Emergent Arm) setting

Up to 120 subjects will be recruited in the primary arm (elective setting).The first 32 subjects will undergo left subclavian artery repair or replacement with the Rapidlink device. After the 32nd subject with only the left subclavian artery repair or replacement with the Rapidlink device has been enrolled, 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 an elective setting.

For the Emergent Arm, 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 emergent setting. Enrollment into the Emergent Arm will begin after the 32ndsubject from the Primary Arm has been enrolled. Investigators are not allowed to enroll into the Emergent Arm until one elective case has been performed.

It is anticipated that up to 150 patients will be recruited over a 12 month period (approximately). Patients will be evaluated at the following timepoints: Pre-procedure, Implant, Discharge/30 days, 3 months, 12 months and 24 months.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)