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.
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 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
Single group
Rapidlink
DeviceThe Rapidlink implant is comprised of a Gelweave graft section (gelatin-sealed woven polyester) attached to a stented section (which utilizes nitinol ring stents), with a 'cuff'' feature joined to the stented section of the implant. The implant is supplied pre-loaded in a single use delivery system which compacts the stented section within a polytetrafluoroethylene (PTFE) sheath at the front of the system.
The absence of a major adverse event (MAE) at 6-month post procedure.
The primary endpoint is the absence of a major adverse event (MAE) at 6-month post procedure. MAE are defined as follows are will be assessed as composite and individually: Permanent disabling stroke Permanent paraplegia/paraparesis Device-related (Rapidlink) reinterventions All-cause mortality * Device-related mortality (arch graft and/or branch graft) * Procedure-related mortality * Not device or procedure related
Technical Success of the Rapidlink portion of the procedure
Technical Success: of the Rapidlink portion of the procedure is a composite endpoint evaluated at 30 days by the implanting physician and is defined as follows: * Successful access to the arterial system * Successful delivery and deployment of the Rapidlink device in the planned location without unplanned vessel coverage * Absence of Rapidlink-related Type I or Type III endoleaks (or resolution by 30 days) as determined by imaging confirmation * Patency of the Rapidlink device (defined as less than 50% stenosis or without the need for re-intervention due to stenosis), * Absence of device deformations requiring unplanned placement of an additional device * Successful withdrawal of the Rapidlink delivery system (without unanticipated corrective action related to the withdrawal)
Clinical Success (Total Arch Repair)
Clinical Success (Total Arch Repair) is defined as: * Absence of lesion-related mortality * Absence of persistent Type I or Type III endoleak\* * Absence of device infection * Absence of aortic thrombosis * Absence of new dissection * Absence of loss of patency (any unanticipated loss of patency of supra-aortic vessels)\*\* * Absence of secondary intervention or conversion to open surgery completed to address a loss of device integrity * Absence of permanent paraplegia/paraparesis, permanent stroke, or laryngeal nerve paralysis that resulted from the initial operation or a secondary intervention to correct the treated supra-aortic vessels connections Clinical Success will be assessed as a composite and all individual elements
Rate of Aortic or supra-aortic vessel rupture
Rate of Aortic or supra-aortic vessel rupture
Rate of Stroke of any type, including transient ischemic attacks
Rate of Stroke of any type, including transient ischemic attacks
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