Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

NCT03214601 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IP-0019-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 12

Brief Summary

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

Thoracic Aorta Aneurysm; Aneurysm, Ruptured; Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

  30 days after the index procedure

Secondary Outcomes (1)

• Composite of the following Criteria

  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

Study Arms (1)

Relay Branch System

EXPERIMENTAL

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

Interventions

penetrating atherosclerotic ulcer, aorta branch cardiovascular implant DEVICE

The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies.

Also known as: Relay Branch System, system, endovascular graft, aortic aneurysm treatment

Relay Branch System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<20.0 mm in diameter and a minimum of 25.0 mm in length.
• Adequate arterial access for introduction and delivery of the Relay Branch System. Note: Alternative methods to gain proper access can be utilized (e.g., iliac conduit)

You may not qualify if:

• Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device
• Aortic angulations (radius) less than 15mm at intended proximal landing zone.
• Ascending aortas that would require the arch graft to be deployed less than 15mm distal to the coronaries
• 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 mechanical aortic valve replacement except for hybrid valves with biological leaflets.
• Major surgical or medical procedure within 45 days prior to the planned procedure or is scheduled for a major surgical or medical procedure within 60 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
• Acute Coronary Syndrome (ACS) including unstable angina
• Severe Congestive Heart Failure (New York Heart Association functional class IV)
• Stroke within 12 months of the planned treatment date

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (12)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Barnes Jewish Hospital at Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania/Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor Scott and White Research Institute

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aneurysm, Ruptured; Aortic Aneurysm

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Luis Sanchez, MD

  Barnes Jewish Hospital, Washington Univ

  PRINCIPAL INVESTIGATOR

• Wilson Szeto, MD

  Penn Presbyterian Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: July 11, 2017
• Study Start: December 4, 2017
• Primary Completion: September 18, 2023
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)