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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Other Specified Injury of Thoracic Aorta
• Intervention / Treatment: Device: Relay Pro Thoracic Stent-Graft System

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • University of California, Irvine
    • Stanford, California, United States, 94305-5639
      • Stanford Medicine
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center / Harvard Medical School
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis University
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Medical Center / Penn Presbyterian
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

  1. 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).
  2. 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relay Pro Thoracic Stent-Graft System; The 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	Device: Relay Pro Thoracic Stent-Graft System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality post-procedure	All-cause mortality at 30 days post-procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During Implantation
Loss of stent-graft patency	Loss of stent-graft patency through 5 years	1 month, 6 months, 12 months, and annually through 5 years
Aortic rupture	Aortic rupture will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media	1 month, 6 months, 12 months, and annually through 5 years
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	1 month, 6 months, 12 months, and annually through 5 years
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	1 month, 6 months, 12 months, and annually through 5 years
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	1 month, 6 months, 12 months, and annually through 5 years
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	1 month, 6 months, 12 months, and annually through 5 years
Aortic expansion	Aortic expansion (> 5mm) compared to the first post-procedural CT	1 month, 6 months, 12 months, and annually through 5 years
Endograft infection	Infection of stent-graft	1 month, 6 months, 12 months, and annually through 5 years
Incidence of open or endovascular secondary interventions	Incidence of open or endovascular secondary interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion	1 month, 6 months, 12 months, and annually through 5 years
Migration	Stent migration (> 10 mm) compared to the first post-procedural CT; formation, or aortic expansion	1 month, 6 months, 12 months, and annually through 5 years
Major adverse events	death, stroke, paralysis formation, or aortic expansion	1 month, 6 months, 12 months, and annually through 5 years
Aortic-related death	formation, or aortic expansion	1 month, 6 months, 12 months, and annually through 5 years
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	During the initial implant attempt
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.	1 month, 6 months, 12 months, and annually through 5 years

Collaborators and Investigators

• Sponsor: Bolton Medical
• Investigators: Principal Investigator: Ben Starnes, MD, University of Washington; Principal Investigator: Ravi Rajani, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): December 22, 2020
• Study Completion (Estimated): November 22, 2025

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Transection; Descending Thoracic Aorta; DTA; Traumatic Injury of the Descending Thoracic Aorta
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Wounds and Injuries; Aortic Dissection
• Other Study ID Numbers: IP-0018-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes