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

Running, not enrolling · Not applicable

Conditions studied: Other Specified Injury of Thoracic Aorta

In brief

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)

Key facts

Study ID

NCT03090230

Run by

Bolton Medical

People needed

50

Starts

2017-04-17

Expected to finish

2025-11-22

Last updated by the study team

2025-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• University of California, Irvine — Irvine, California, United States
• Stanford Medicine — Stanford, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Indiana University Health — Indianapolis, Indiana, United States
• University of Iowa Hospital and Clinic — Iowa City, Iowa, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center / Harvard Medical School — Boston, Massachusetts, United States
• St. Louis University — St Louis, Missouri, United States
• Atrium Health — Charlotte, North Carolina, United States
• University Hospitals — Cleveland, Ohio, United States
• University of Pennsylvania Medical Center / Penn Presbyterian — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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