Thoracic Aortic Aneurysm, Thoracic Aortic Dissection Bulging or stretching of main blood vessel, Tear in the inner lining of the body's main blood vessel
Conditions
Interventions
This study investigates the performance of a Rapidlink system to treat and support certain large blood vessels during heart surgery. These blood vessels, such as the left subclavian artery, the left c
Sponsors
Vascutek Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is aged 18 years or over on date of consentWritten 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 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 Instructions for UseAnticipated need to use Rapidlink for the repair or replacement of the left subclavian artery, left common carotid artery, and/or innominate artery during the open surgical repairPatient has an 8—15 mm inner diameter (target supra-aortic vessel)The diameters of the patient’s target supra-aortic vessel(s), fall within the range specified in the IFU
Exclusion criteria
Exclusion criteria: Patients meeting the following criteria will be excluded from the study: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 lengthPatient cannot receive anticoagulation / antiplatelet therapy during or after the index procedure as per the protocolPatient has uncontrolled hypercoagulationPatient has a condition which may compromise or prevent the necessary imaging requirementsPatient 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 investigatorPatient has known sensitivity to materials used in the components of the Rapidlink device, as detailed in the device IFU Patient has a ruptured aortaPatient has active endocarditis or an active infective disorder of the aortaPatient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedurePatient 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 studyPatient is female and is pregnant, lactating, 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 anomalyPatient 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-treatedPatient has a co-morbidity causing expected survival to be less than 1 yearPatient 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 procedurePatient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as the absence of Major Adverse Events at 6-months post-procedure. Major adverse events are defined as follows:Permanent disabling strokePermanent paraplegia/paraparesisDevice-related (Rapidlink) reinterventionsAll-cause mortalityDevice-related mortality (arch graft and/or branch graft)Procedure-related mortalityNot device or procedure related | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary Endpoints are as follows: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 systemSuccessful delivery and deployment of the Rapidlink device in the planned location without unplanned vessel coverageAbsence of Rapidlink-related Type I or Type III endoleaks (or resolution by 30 days) as determined by imaging confirmationPatency 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 deviceSuccessful withdrawal of the Rapidlink delivery system (without unanticipated corrective action related to the withdrawal)Technical success can include the use of additional modular components, stents, or angioplasty and adjunctive surgical procedures at the time of the primary procedure. Any Rapidlink-related unplanned endovascular or surgical procedure to achieve technical success will be noted as assisted primary technical success.The following endpoints will be assessed at every follow-up time point:Clinical Success (Total Arch Repair) is defined as:Absence of lesion-related mortalityAbsence of persistent Type I or Type III endoleak Absence of device infectionAbsence of aortic thrombosisAbsence of new dissectionAbsence 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 integrityAbsence 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 connectionsIndividual components of the primary endpointIndividual components of clinical successAortic or supra-aortic vessel ruptureStroke of any type, including tr | — |
Countries
Austria, Germany, Italy, Netherlands, Switzerland, United Kingdom, United States
Contacts
Public ContactSM Macluskie
Vascutek Limited
Outcome results
None listed