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Thoracic Aorta AneurysmRelayBranchNCT03214601

Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

A study testing penetrating atherosclerotic ulcer, aorta branch cardiovascular implant in people with Thoracic Aorta Aneurysm and Aneurysm, Ruptured, run by Bolton Medical at 12 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
penetrating atherosclerotic ulcer, aorta branch cardiovascular implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
12 sitesUnited States
Study dates
4 Dec 2017to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • PAU within the ascending aorta, aortic arch, or proximal descending thoracic aorta (DTA) with or without intramural hematoma (IMH)
  • 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.
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  • 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)
  • Considered high risk or prohibitive 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.

Who cannot join

  • 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
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  • 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
  • Myocardial infarction within 3 months of the planned treatment date.
  • Chronic atrial fibrillation or other hypercoagulable condition that requires treatment with anticoagulants or presence of left atrial appendage thrombus
  • Severe pulmonary disease (documented FEVI <30% or as assessed by the study physician) at screening
  • Acute renal failure (defined as serum creatinine > 2.5mg/dL Note: Patients that have chronic renal failure and are managed medically or through hemodialysis, and can tolerate the follow-up imaging schedule can be included.
  • Significant carotid bifurcation disease (>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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Duke University

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32608

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Southern California

    Los Angeles, California, 90033

  • Columbia University Medical Center

    New York, New York, 10032

  • Hospital of the University of Pennsylvania/Penn Presbyterian

    Philadelphia, Pennsylvania, 19104

  • Baylor Scott and White Research Institute

    Plano, Texas, 75093

  • Barnes Jewish Hospital at Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
penetrating atherosclerotic ulcer, aorta branch cardiovascular implant
Medical subject headings
Aortic Aneurysm, Thoracic, Aneurysm, Ruptured, Aortic Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • penetrating atherosclerotic ulcer, aorta branch cardiovascular implantDevice

    Also called Relay Branch System, system, endovascular graft, aortic aneurysm treatment

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

Study groups in NCT03214601
Study groupRoleWhat they receive
Relay Branch SystemExperimentalSubjects 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.
Receives: Device: penetrating atherosclerotic ulcer, aorta branch cardiovascular implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days after the index procedure

Secondary outcomes (1)

  1. 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
    3. 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
    4. Successful withdrawal of the delivery system
    • Patency of all endograft components at 30 days

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study start4 Dec 2017
  3. Primary completion18 Sep 2023
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03214601
Sponsor's protocol ID
IP-0019-16
Acronym
RelayBranch
Status last verified
Apr 2025
First submitted
25 Jun 2017
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing penetrating atherosclerotic ulcer, aorta branch cardiovascular implant in people with Thoracic Aorta Aneurysm and Aneurysm, Ruptured, run by Bolton Medical at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Major Adverse Events (MAEs) (time frame: 30 days after the index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03214601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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