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

NCT03090230 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IP-0018-16
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 16

Brief 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)

Conditions

Other Specified Injury of Thoracic Aorta

Keywords

Descending Thoracic Aorta; DTA; Transection; Traumatic Injury of the Descending Thoracic Aorta

Outcome Measures

Primary Outcomes (1)

• Mortality post-procedure

  All-cause mortality at 30 days post-procedure

  30 days

Secondary Outcomes (15)

• Successful device delivery and deployment

  During Implantation

• Loss of stent-graft patency

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

• Aortic rupture

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

• Stent fractures in the attachment zone

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

• Endoleaks

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

Study Arms (1)

Relay Pro Thoracic Stent-Graft System

EXPERIMENTAL

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

Interventions

Relay Pro Thoracic Stent-Graft System DEVICE

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.

Relay Pro Thoracic Stent-Graft System

Eligibility Criteria

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

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (16)

University of California, Irvine

Irvine, California, 92868, United States

Location

Stanford Medicine

Stanford, California, 94305-5639, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospital and Clinic

Iowa City, Iowa, 52242, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center / Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania Medical Center / Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Ben Starnes, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Ravi Rajani, MD

  Emory University

  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: 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.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 24, 2017
• Study Start: April 17, 2017
• Primary Completion: December 22, 2020
• Study Completion: November 22, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)