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Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System (RelayBranch)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03214601
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

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.


Condition or disease Intervention/treatment Phase
Thoracic Aorta Aneurysm Aneurysm, Ruptured Aortic Aneurysm Device: penetrating atherosclerotic ulcer, aorta branch cardiovascular implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Composite of Major Adverse Events (MAEs) [ Time Frame: 30 days after the index procedure ]

    The primary safety outcome determined by the rate of MAEs, including

    • All-cause mortality
    • Stroke, excluding transient ischemic attack (TIA)
    • Paralysis, excluding paraparesis


Secondary Outcome Measures :
  1. Technical success evaluation at 24 hours and 30 days [ Time Frame: Technical success will be evaluated in 2 stages; the first evaluation occurs within 24 hours of the implant procedure. Technical success is then re-evaluated again 30 days post operation to ensure the graft placement was successful as outlined above ]

    Success is defined as a successful delivery of the device through the vasculature, successful deployment of the device at the intended location, patent stent-graft without significant (>50%) stenosis and patency of all endograft components at 30 days.

    In addition, complete sealing of the aortic pathology at 30 days, as defined by the absence of type I and III endoleak, complete coverage of the ulcer in PAU cases, and isolation of the primary entry tear in dissection cases.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03214601


Contacts
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Contact: Ann Glasse 954-838-9699 a.glasse@terumoaortic.com
Contact: Gretchen Wild 954-838-9699 g.wild@terumoaortic.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Janet Luong    323-865-1251    Janet.Luong@med.usc.edu   
Principal Investigator: Sukgu Han, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Jessica Cobb, PhD    352-273-7837    jessica.cobb@surgery.ufl.edu   
Contact: Deepal Shah, MD       Deepal.Shah@surgery.ufl.edu   
Principal Investigator: George Arnaoutakis, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jayne Thompson, RN, CCRC    404-778-4920    sjdanle@emory.edu   
Principal Investigator: Bradley Leshnower, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Fabienne M Francois, MD    410-328-8149    ffrancois@som.umaryland.edu   
Contact: Manal Al-Suqi    410-328-9409    MaAl-suqi@som.umaryland.edu   
Principal Investigator: Bradley Taylor, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Tara Bresnahan, RN,BSN, CCRC    617-643-2731    TBRESNAHAN2@mgh.harvard.edu   
Contact: Amanda Kirshkain, MS    617-726-2264    ajkirshkaln@mgh.harvard.edu   
Principal Investigator: Matthew Eagleton, MD         
United States, Missouri
Barnes Jewish Hospital at Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Julie Wilson, RN    314-362-6257    wilsonj@wustl.edu   
Contact: Ashley Burgess       ashley.burgess@wustl.edu   
Principal Investigator: Luis Sanchez, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Danielle Griffith    212-342-9071    dsg2153@cumc.columbia.edu   
Contact: Claudia Musat    212-342-4102    cm2065@cumc.columbia.edu   
Principal Investigator: Hiroo Takayama, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Hillary Hood    919-613-6569    hillary.hood@duke.edu   
Principal Investigator: Chad Hughes, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Robert Stolz    216-444-3650    stolzr@ccf.org   
Principal Investigator: Eric Roselli, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania/Penn Presbyterian Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marisa Konig, BA, RN, MSN    215-662-8456    Marisa.Konig@uphs.upenn.edu   
Principal Investigator: Wilson Szeto, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Zaida Bisbal    713-798-5568    Zaida.Bisbal2@bcm.edu   
Principal Investigator: Jospeh Coselli, MD         
Baylor Scott and White Research Institute Recruiting
Plano, Texas, United States, 75093
Contact: Kathryn Shinn    469-814-4981    Kathryn.Shinn@BSWHealth.org   
Principal Investigator: William Brinkman, MD         
Sponsors and Collaborators
Bolton Medical
Investigators
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Principal Investigator: Luis Sanchez, MD Barnes Jewish Hospital, Washington Univ
Principal Investigator: Wilson Szeto, MD Penn Presbyterian Medical Center
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Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT03214601    
Other Study ID Numbers: IP-0019-16
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aneurysm, Ruptured
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases