Aneurysmal Disease, Aneurysm of Aorta, Thoracic, Aorta, Thoracic Pathologies, Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases
Conditions
Keywords
Vascular Prosthesis, Replacement or bypass of disease vessels, aneurysmal disease, Aortic branch vessels, Open aortic arch repair, aneurysm, dissection, Supra-aortic Vessels, Frozen Elephant Trunk, Left Subclavian Artery
Brief summary
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.
Detailed 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.
Interventions
DEVICERapidlink
The 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.
Sponsors
Vascutek Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The absence of a major adverse event (MAE) at 6-month post procedure. | 6 months 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of the Rapidlink portion of the procedure | 30 days post-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) | At discharge/30 days, 6-Months, 12 Months and 24 Months post-procedure | 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 | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of Aortic or supra-aortic vessel rupture |
| Rate of Stroke of any type, including transient ischemic attacks | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of Stroke of any type, including transient ischemic attacks |
| Rate of Pseudoaneurysm in the treated segment | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of Pseudoaneurysm in the treated segment of the aorta |
| Device-related serious adverse events | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of Device-related serious adverse events |
| Rate of endoleaks | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of core laboratory imaging confirmed endoleak of any type |
| Rate of migration of the Rapidlink Device | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Migration defined as: Movement (caudal and/or cranial) of device of \>10 mm as compared to first post-procedural imaging (e.g., discharge/30-day). |
| Rate of Loss of Device (Rapidlink) integrity | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Fracture of stent and or disruption of fabric or suture material as confirmed by imaging. |
| Patency related observations (e.g., asymptomatic loss of patency, stenosis) of the Rapidlink device | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of patency related observations by type, confirmed by imaging |
| Rate of Lesion or device-related secondary interventions | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Rate of lesion or device-related secondary interventions |
| Clinical utility measures | At discharge/30 days, 6-months, 12 months and 24 months post-procedure | Duration of procedure and Implantation of Device (Hours) |
| Clinical Utility Measures | At discharge/30days, 6 months, 12 months and 24 months post-procedure | Length of Duration of hospital stay (days) |
Countries
Austria, Germany, Netherlands, United Kingdom, United States
Contacts
CONTACTSarah Macluskie
CONTACTMichelle Durnan
Outcome results
None listed