Thoraflex™ Hybrid IDE Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02724072|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2016
Last Update Posted : November 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Aortic Aneurysm Aortic Dissection Aortic Rupture||Device: Thoraflex™ Hybrid Device||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure.|
|Actual Study Start Date :||August 22, 2016|
|Actual Primary Completion Date :||June 24, 2019|
|Estimated Study Completion Date :||July 2021|
Experimental: Thoraflex™ Hybrid Device.
Plexus™ 4 and Ante-Flo™ configurations will be included in this study.
Device: Thoraflex™ Hybrid Device
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.
- 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 [ Time Frame: ≤ 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).
- Device Technical Success [ Time Frame: At exit from OR (i.e. completion of surgical procedure) ]
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.
- Procedural Success [ Time Frame: At discharge/30 days ]
Technical Success, with absence of the following:
Major adverse ischemic events:
- 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.
- Treatment Success [ Time Frame: At discharge/30 days and all post-procedural intervals ]
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
Technical success with absence of all of above criteria is required in order to achieve treatment success.
- Individual Patient Success [ Time Frame: At 1 year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724072
|United States, California|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94305-5407|
|United States, Georgia|
|Emory Saint Joseph's Hospital|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5853|
|United States, New York|
|The Mount Sinai Hospital|
|New York, New York, United States, 10029|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|NY Presbyterian Weill Cornell|
|New York, New York, United States, 10065|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 10104|
|University of Pittsburgh Medical Center (UPMC) Presbyterian|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Baylor St. Luke's|
|Houston, Texas, United States, 77030|
|University of Texas Houston- Memorial Hermann Texas Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Joseph S Coselli||Baylor St. Luke's|