The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of ascending aorta. The study will also assess safety and early clinical outcomes in patients who receive an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. Lastly the study will assess the safety and clinical outcomes of patients who receive a Thoraflex™ Hybrid Device for treatment of a ruptured aorta. Patients will be followed for 3 years. The Primary Endpoint will be freedom from defined Major Adverse Events (MAE) occurring ≤ 1 year post-procedure.
Vascutek Ltd has developed the Thoraflex™ Hybrid Device (Plexus™ 4 and Ante-Flo™) for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta, with or without involvement of the ascending aorta, in cases of aneurysm and/or dissection. The Thoraflex™ Hybrid Device may be considered a development of the Elephant Trunk (ET) grafts with the addition of a stented distal section. In some cases this will allow for a single stage procedure to be carried out, dependent on the length of affected vessel. As the device is fully sealed and has a collar to aid anastomosis, it removes the requirement for in situ sealing and the suturing together of two devices, thereby reducing cardiopulmonary bypass (CPB) time and overall procedure time. By reducing the procedure time and negating the need for as many subsequent procedures, this method could greatly improve the success of this procedure and may improve patient outcomes. The ability to treat complex anatomies in addition to reducing procedure and CPB time, justify the investigation of the Thoraflex™ Hybrid Device. Safety and effectiveness data for subjects treated with the Thoraflex™ Hybrid Device will be compared to historical data from subjects treated using standard ET surgical repair. It is anticipated that up to 83 patients will be recruited over a 14 month period (approximately). Patients will be evaluated at the following time points: Pre-procedure, Implant, Discharge/30 days, 3 months, 12 months, 24 months and 36 months. An additional visit may be performed for patients who undergo an extension procedure within 1 year of Thoraflex™ Hybrid Device implantation. 65 patients will be recruited to the primary study group (maximum 19 per site). An additional group of patients with a ruptured aorta may also be recruited (up to approximately 18 patients across all sites). A historical control population has been derived from a comparable patient population who received treatment for thoracic aortic disease using the current standard of care, which is the conventional (2-stage) elephant trunk technique. Using data from the comparator population a Performance Goal Target has been set at 57.4%. The study will be deemed a success if the lower limit of the 95% confidence interval, associated with the proportion of study patients who are free from the defined composite Major Adverse Events (permanent stroke, permanent paraplegia/paraparesis, unanticipated aortic related re-operation and all-cause mortality) at 1 year post procedure, is greater than 57.4%. Only patients included in the main study group will be included in the Performance Goal Analysis; patients recruited into the additional Aortic Rupture group will not be included in the primary endpoint analysis. All patients in the main study group will be included in the analysis regardless of whether or not an extension procedure has been performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Single-use medical device sterilized by ethylene oxide which is pre-loaded into a delivery system. The device comprises a gelatin sealed vascular graft combined with a stented graft.
Stanford University Medical Center
Palo Alto, California, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
The Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
NY Presbyterian Weill Cornell
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Presbyterian
Pittsburgh, Pennsylvania, United States
...and 2 more locations
Proportion of patients who are free from composite Major Adverse Events (Permanent stroke, Permanent paraplegia/paraparesis, Unanticipated aortic-related re-operation, All-cause mortality) at 1 year post-procedure
Freedom from the following composite Major Adverse Events (MAE) occurring ≤ 1 year post-procedure: * Permanent stroke * Permanent paraplegia/paraparesis * Unanticipated aortic-related re-operation (excluding re-operation for bleeding) * All-cause mortality All relevant events will be adjudicated by CEC. Data will be analysed and presented in a binary format (i.e. Freedom from the listed AE's - Yes/No).
Time frame: ≤ 1 year post-procedure
Device Technical Success
Device Technical Success is defined as: * Successful delivery and accurate placement of the intraluminal part of the graft at the intended implantation site and retrieval of the device delivery system, and * Patency of the graft (including branches) and absence of device deformations (e.g., kinks) requiring unplanned placement of additional devices within the graft, and * No need for unanticipated or emergency surgery (e.g., return to bypass after initial removal of aortic cannula or reversal of heparin) or re-intervention (e.g. placement of additional unplanned endoluminal devices within the frozen segment) related to the device or procedure. All of the above criteria are required to be met in order to achieve technical success.
Time frame: At exit from OR (i.e. completion of surgical procedure)
Procedural Success
Technical Success, with absence of the following: * Death * Major adverse ischemic events: * Paraplegia * Paraparesis * Disabling stroke * New ischemia * Distal procedure-related thromboembolic adverse event * Aortic and valve complications: * Aortic rupture * Increase in aortic regurgitation grade of greater than 1 * General procedure related complications: * Peri-procedural myocardial infarction or need for urgent or emergent PCI/CABG * New onset renal failure requiring dialysis * Renal dysfunction or volume overload requiring ultrafiltration * Bowel ischemia requiring surgery or intervention * Life-threatening bleed * Severe Heart Failure (HF) or hypotension * Prolonged Intubation \> 48 hours * Pseudoaneurysm of any graft surgical suture line * Additional unplanned surgical or interventional procedures related to device Technical success with absence of all of above criteria is required in order to achieve procedural success.
Time frame: At discharge/30 days
Treatment Success
Device Technical Success, with absence of the following: * Aortic enlargement in the region encompassed by the initial lesion * Aortic rupture * Fistula formation * Lesion-related mortality * Loss of device integrity * Residual or new Type III endoleak * The following subset of major adverse events: * Disabling stroke within 30 days of the procedure * Paraplegia * Paraparesis Technical success with absence of all of above criteria is required in order to achieve treatment success.
Time frame: At discharge/30 days and all post-procedural intervals
Individual Patient Success
Treatment Success at one year, and: * Post-operative return to normal activities - employment, household activities, social life, and hobbies, and * Improved Health Related Quality of Life Measure (HRQoL) - EQ-5D Treatment success and the above criteria are required to be met in order to achieve individual patient success.
Time frame: At 1 year
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