Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥18 years
  • Anatomy that would require coverage of the innominate 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 type B aortic dissection or IMH with time from symptom onset to diagnosis ≥ 60 days without malperfusion of the viscera, kidneys, spinal cord, or lower extremities and 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

- 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 proximal to the innominate artery and distal attachment zone distal to the left subclavian artery.

1. The length of the proximal attachment zone is 30 mm of ascending aorta that meets the oversizing requirement, plus 10 mm of ascending aorta with a diameter equal or less than the proximal diameter of the arch graft.

2. The length of the distal attachment zone should be 20mm minimum.

3. 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 innominate and left common carotid arteries with diameters ranging between 7 mm and 20 mm

- Innominate and left common carotid attachment zone length of 25 mm minimum.

- Vascular dimensions must be in the range that can be safely treated with the Relay Branch System

- Adequate arterial access for introduction and delivery of the Relay Branch System. Alternative methods to gain proper access can be utilized (e.g., iliac conduit)

- Considered high risk for conventional surgery by treating physician or aortic team

- Must be willing to comply with the follow-up evaluation schedule

- Subject or legally authorized representative must sign the informed consent form prior to implant.

Exclusion Criteria

  • Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device
  • Pre-procedure occlusion or planned coverage of both subclavian arteries
  • Anatomic variants which would compromise circulation to both vertebral arteries after placement of the stent-graft
  • Prior endovascular repair in the ascending/descending thoracic aorta or aortic arch. The device may not be placed within any prior endovascular graft
  • Concomitant aneurysm/disease of the abdominal aorta requiring repair
  • Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure
  • Prior aortic valve replacement (mechanical valve)
  • Major surgical or medical procedure within 45 days prior to the planned procedure or is scheduled for a major surgical or medical procedure within 45 days post implantation. Except for any planned procedures for the prospective stent-graft placement, e.g., left subclavian artery bypass or transposition
  • Untreatable allergy or sensitivity to contrast media or device components
  • Blood coagulation disorder or bleeding diathesis in which the treatment cannot be suspended for one week pre and post repair
  • Coronary artery disease with unstable angina
  • Severe Congestive Heart Failure (New York Heart Association functional class IV)
  • Stroke and/or myocardial infarction within 3 months of the planned treatment date
  • Pulmonary disease requiring routine (daily or nightly) need for oxygen therapy outside the hospital setting
  • Acute renal failure or renal insufficiency and not on renal replacement therapy or dialysis
  • Significant carotid bifurcation disease (>70% diameter reduction by duplex ultrasound or angiography)
  • Hemodynamic instability
  • Active systemic infection and/or mycotic aneurysms
  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
The Relay Branch System is intended for treating thoracic aortic arch pathologies requiring coverage of the innominate and left common carotid arteries. The system includes a graft with a proximal landing zone in the proximal aorta and branch grafts that extend into the innominate and left common carotid arteries. The arch graft and branch grafts are composed of self-expanding nitinol stents sutured to polyester vascular graft fabric, creating an exoskeleton
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Relay Branch System
Subjects who receive the Relay Branch System for repair which includes those with aneurysmal disease, penetrating atherosclerotic ulcer (PAU), and chronic uncomplicated Type B aortic dissection.
  • Device: penetrating atherosclerotic ulcer, aorta branch cardiovascular implant
    The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies.
    Other names:
    • Relay Branch System
    • system, endovascular graft, aortic aneurysm treatment

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Fabienne M Francois, MD
410-328-8149
ffrancois@som.umaryland.edu

More Details

Status
Recruiting
Sponsor
Bolton Medical

Study Contact

Ann Glasse
954-838-9699
a.glasse@terumoaortic.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.