The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
This Early Feasibility Study (EFS) protocol describes the clinical study requirements for the Relay Branch System; a device designed to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies. As an EFS, this investigation is intended to provide proof of principle and initial clinical safety data on the Relay Branch System. The study is planned as an initial investigation of the device for aortic arch and proximal descending thoracic aortic aneurysmal disease, PAU (including IMH) and uncomplicated chronic Type B aortic dissection (including IMH). The study will yield information on procedural techniques; assessing the safety and effectiveness of the device at the index procedure and at 30 days, focusing on device delivery and deployment, and circulatory exclusion of the pathologic process. As a branched device, patency of the endograft branches will also be assessed. The study will evaluate three-dimensional (3D) imaging data, both at baseline and through follow-up. Baseline 3D anatomy will augment information on the precise anatomic configuration of patients presenting aortic arch pathology treatable with the device. Follow-up imaging will provide information on the effectiveness of the device with respect to endoleaks in patients with aneurysms, sealing of dissections, PAU and IMH, and stability of the device at the deployed position, response, endograft patency, and short-term device integrity. The data from this EFS will yield insights into the following aspects of the device, preceding a traditional feasibility or pivotal study: * The clinical safety of the device-specific aspects of the procedure, * Determination of delivery and deployment of the device, * Operator-dependent aspects of device use, * Human factors associated with the design and use of the device, * Safety of the device as assessed by device-related adverse events, * Effectiveness of the device in performing its intended purpose over short-term follow-up. Observations from the study will guide the instructions for use (IFU) for the device. Finally, the study will collect imaging data to augment the current use conditions data set. It is anticipated that information collected will be used to make applicable design changes, or be combined with a prospective, investigational device exemption (IDE) study for submission of an original premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for approval to commercially distribute the system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies.
University of Southern California
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Barnes Jewish Hospital at Washington University
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania/Penn Presbyterian
Philadelphia, Pennsylvania, United States
...and 2 more locations
Composite of Major Adverse Events (MAEs)
The primary safety outcome determined by the rate of MAEs, including * All-cause mortality * Disabling stroke: a Modified Rankin Score (mRS) of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline * Permanent Paralysis/Paraparesis * Spontaneous Myocardial Infarction according to the SCAI definition * Renal Failure * Procedural Blood Loss \>1,000mL
Time frame: 30 days after the index procedure
Composite of the following Criteria
* Acute technical success evaluation, beginning with the insertion of the introducer sheath and as a composite of the following: 1. Success is defined as a successful delivery of the device through (i.e. ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery): 2. Successful deployment of the device as defined as i. Deployment of the endovascular stent-graft at the intended implantation site; ii. Patency (\<50%) of all components of the implant with absence of device deformations requiring unplanned placement of an additional device within the endovascular stent-graft; and iii. absence of inadvertent covering of aortic branch vessels; and c. Successful withdrawal of the delivery system * Patency of all endograft components at 30 days
Time frame: Technical success will be evaluated in 2 stages; the first evaluation occurs during the implant procedure. Technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above
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