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.
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Mortality post-procedure — 30 days All-cause mortality at 30 days post-procedure
Trial sites (16)
Facility
City
Region
Status
University of California, Irvine
Irvine
California
Stanford Medicine
Stanford
California
Yale School of Medicine
New Haven
Connecticut
Grady Memorial Hospital
Atlanta
Georgia
Indiana University Health
Indianapolis
Indiana
University of Iowa Hospital and Clinic
Iowa City
Iowa
University of Maryland Medical Center
Baltimore
Maryland
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston
Massachusetts
St. Louis University
St Louis
Missouri
Atrium Health
Charlotte
North Carolina
University Hospitals
Cleveland
Ohio
University of Pennsylvania Medical Center / Penn Presbyterian
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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