RelayBranch

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.

Inclusion Criteria:

• Age ≥18 years

• Anatomy that would require coverage of the brachiocephalic trunk (BCT) and/or left carotid arteries if a non-branch endograft were implanted

• At least one of the following: a. Aneurysm of the ascending aorta, aortic arch, or proximal descending aorta that

Meets at least one of the following: i. ≥ 5.5 cm in diameter ii. ≥ 4.0 cm in diameter

that has increased in size by 0.5 cm in the last 6 months iii. Measures twice the size

of the normal aorta diameter iv. Is saccular in configuration

b. PAU within the ascending aorta, aortic arch, or proximal descending thoracic aorta

(DTA) with or without intramural hematoma (IMH)

c. Chronic, uncomplicated aortic dissection distal to the BCT (type B), with either

aortic diameter ≥5.5 cm or ≥4.0 cm with an increase in size by 0.5 cm in the last 6

months d. IMH distal to the BCT with recurrent symptoms, i.e. hypertension or

intractable pain, despite best medical therapy.

• A non-aneurysmal proximal aortic neck diameter ranging between 28 mm and 43 mm and a non-aneurysmal distal aortic neck diameter ranging between 19 mm and 43 mm.

• A proximal attachment zone of the arch graft, meeting the oversizing requirement, must be a minimum of 25mm in length when measured on the inner curve of the ascending aorta, proximal to the BCT.

• Total length from the coronaries to the proximal edge of the BCT must be a minimum of 70mm.

• The length of the distal landing zone should be 20mm minimum.

• Coverage of the left subclavian artery is permitted. Revascularization of the left subclavian artery may be considered in all cases by the treating physician and, especially, in anatomies where revascularization is determined to be clinically necessary

• The distal landing zone must contain a straight segment (non-tapered, non-reverse tapered; defined by < 10% diameter change) with length equal to or greater than the required attachment length of the intended device

• Non-aneurysmal BCT and left common carotid arteries with diameters ranging > 6.0mm across the entire length of the treatment zone.

• Distal branch landing zone must be 70% diameter reduction by duplex ultrasound or angiography)

• Hemodynamic instability

• Active systemic infection at the time of treatment

• Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements

• Connective tissue disorders, mycotic aneurysms, or infected aorta

• Less than two-year life expectancy

• Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation

• Currently pregnant or planning to become pregnant during the course of the study

• Medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up