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Other Specified Injury of Thoracic AortaNCT03090230

Study of the Relay Pro® Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

A study testing Relay Pro Thoracic Stent-Graft System in people with Other Specified Injury of Thoracic Aorta, run by Bolton Medical at 16 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 investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Other Specified Injury of Thoracic Aorta
What is being tested?
Relay Pro Thoracic Stent-Graft System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
16 sitesUnited States
Study dates
17 Apr 2017to 22 Nov 2025
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 greater than 18 years
  • Subject must have a traumatic injury of the descending thoracic aorta that occurred no more than 30 days prior to the planned stent implant procedure
  • Proximal and distal landing zones with diameter between 19 mm and 42 mm.
  • Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery.
  • The length of the attachment zones will depend on the intended stent graft diameter.
  • The proximal attachment zone should be: i. 15 mm for 22 - 28 mm grafts with bare stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm grafts with bare stent (25 mm for RelayPro grafts with non-bare stent).
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  • The distal attachment zone should be 20 mm for all Relay Pro grafts.
  • 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
  • Proximal and distal attachment zones containing a straight segment (non-tapered, non-reverse tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.
  • Adequate iliac or femoral artery access for introduction of the RelayPro delivery system. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
  • Subject willing to comply with the follow-up evaluation schedule.
  • Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment

Who cannot join

  • Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
  • Planned coverage of left carotid or celiac arteries; or anatomic variants that may compromise circulation to the carotid, vertebral, or innominate arteries after device placement, and are not amenable to subclavian revascularization
  • Prior endovascular or surgical repair in the DTA. The device may not be placed within any prior endovascular or surgical graft.
  • Concomitant aneurysm/disease of the ascending aorta, aortic arch, or 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.
  • Untreatable allergy or sensitivity to contrast media or device components.
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  • Known or suspected connective tissue disorder.
  • Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or 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 the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
  • Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
  • Hemodynamically unstable.
  • Active systemic infection and/or mycotic aneurysms.
  • Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
  • Injury Severity Score of 75.
  • 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 Investigator believes may interfere with treatment or follow-up.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center / Harvard Medical School

    Boston, Massachusetts, 02215

  • Atrium Health

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • University Hospitals

    Cleveland, Ohio, 44106

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • University of Iowa Hospital and Clinic

    Iowa City, Iowa, 52242

  • University of California, Irvine

    Irvine, California, 92868

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • University of Pennsylvania Medical Center / Penn Presbyterian

    Philadelphia, Pennsylvania, 19104

  • University of Washington

    Seattle, Washington, 98105

  • St. Louis University

    St Louis, Missouri, 63110

  • Stanford Medicine

    Stanford, California, 94305-5639

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Traumatic Injury of the Descending Thoracic Aorta

The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA)

Read the detailed description

This is a prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the DTA in subjects who are candidates for endovascular repair.The primary objective of the study is all-cause mortality at 30 days post procedure.

The secondary objectives of the trial will include descriptive analyses of procedural and post-procedural observations through 5 years of follow-up.

Being tested
Relay Pro Thoracic Stent-Graft System
Keywords
Descending Thoracic Aorta, DTA, Transection, Traumatic Injury of the Descending Thoracic Aorta

What participants receive

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

  • Relay Pro Thoracic Stent-Graft SystemDevice

    RelayPro Thoracic Stent-Grafts are designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta (DTA). The device is designed specifically for use in the thoracic aorta.

Study groups in NCT03090230
Study groupRoleWhat they receive
Relay Pro Thoracic Stent-Graft SystemExperimentalThe Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System
Receives: Device: Relay Pro Thoracic Stent-Graft System

What is being measured

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

  1. Mortality post-procedure

    All-cause mortality at 30 days post-procedure

    Measured: 30 days

Secondary outcomes (15)

  1. Successful device delivery and deployment

    Successful delivery and deployment of the device, including withdrawal of the delivery system, will be assessed with angiography during the index procedure at the Treatment Visit.

    Measured: During Implantation

  2. Loss of stent-graft patency

    Loss of stent-graft patency through 5 years

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  3. Aortic rupture

    Aortic rupture will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  4. Stent fractures in the attachment zone

    Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  5. Endoleaks

    Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  6. Compression of stent-graft

    Extra-luminal compression of the stent-graft will be assessed at each follow-up visit with xrays, CT scans, or MRIs for subjects unable to tolerate contrast media

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  7. Erosion and/or extrusion

    Erosion and extrusion will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  8. Aortic expansion

    Aortic expansion (> 5mm) compared to the first post-procedural CT

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  9. Endograft infection

    Infection of stent-graft

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  10. Incidence of open or endovascular secondary interventions

    Incidence of open or endovascular secondary interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  11. Migration

    Stent migration (> 10 mm) compared to the first post-procedural CT; formation, or aortic expansion

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  12. Major adverse events

    death, stroke, paralysis formation, or aortic expansion

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  13. Aortic-related death

    formation, or aortic expansion

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

  14. Vascular access complications

    The Time Frame for reporting is during the Treatment Visit. Data should be captured upon conclusion of the Treatment Visit. Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system

    Measured: During the initial implant attempt

  15. All-cause mortality

    All causes where subject death is the result of a serious and device- or procedure related adverse effect. Unrelated and accidental deaths, for example a subject death due to injuries sustained from a gunshot wound, would not be included in the evaluation.

    Measured: 1 month, 6 months, 12 months, and annually through 5 years

Timeline

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

  1. First posted24 Mar 2017
  2. Study start17 Apr 2017
  3. Primary completion22 Dec 2020
  4. Study completion22 Nov 2025 (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
Subject must have a traumatic injury of the descending thoracic aorta that occurred no more than 30 days prior to the planned stent implant procedure. All subjects enrolled, will be included in the patient population for the primary analysis. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the secondary analyses.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03090230
Sponsor's protocol ID
IP-0018-16
Status last verified
Apr 2025
First submitted
7 Mar 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

Publications

  • Starnes BW, Rajani RR, Rossi P, Singh N, Benarroch-Gampel J, Cho JS, Nassiri N, Smeds MR, Kalapatapu V, Stern JR, Kabutey NK, Corvera J; RelayPro Investigators. Early survival benefit of a low-profile endograft in blunt traumatic aortic injury. J Vasc Surg. 2024 Sep;80(3):678-684.e1. doi: 10.1016/j.jvs.2024.04.051. Epub 2024 Apr 25.

    PubMed 38677660

Questions about this trial

What is this clinical trial studying?

A study testing Relay Pro Thoracic Stent-Graft System in people with Other Specified Injury of Thoracic Aorta, run by Bolton Medical at 16 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 12 inclusion and 21 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 16 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?

Mortality post-procedure (time frame: 30 days). 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 NCT03090230, which also lists 1 linked publication.

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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