Other Specified Injury of Thoracic Aorta Clinical Trial
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
| Verified date | November 2023 |
| Source | Bolton Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | November 22, 2025 |
| Est. primary completion date | December 22, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Grady Memorial Hospital | Atlanta | Georgia |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center / Harvard Medical School | Boston | Massachusetts |
| United States | Atrium Health | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | University Hospitals | Cleveland | Ohio |
| United States | Indiana University Health | Indianapolis | Indiana |
| United States | University of Iowa Hospital and Clinic | Iowa City | Iowa |
| United States | University of California, Irvine | Irvine | California |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Yale School of Medicine | New Haven | Connecticut |
| United States | University of Pennsylvania Medical Center / Penn Presbyterian | Philadelphia | Pennsylvania |
| United States | St. Louis University | Saint Louis | Missouri |
| United States | University of Washington | Seattle | Washington |
| United States | Stanford Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bolton Medical |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality post-procedure | All-cause mortality at 30 days post-procedure | 30 days | |
| Secondary | 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 | |
| Secondary | Loss of stent-graft patency | Loss of stent-graft patency through 5 years | 1 month, 6 months, 12 months, and annually through 5 years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Aortic expansion | Aortic expansion (> 5mm) compared to the first post-procedural CT | 1 month, 6 months, 12 months, and annually through 5 years | |
| Secondary | Endograft infection | Infection of stent-graft | 1 month, 6 months, 12 months, and annually through 5 years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Major adverse events | death, stroke, paralysis formation, or aortic expansion | 1 month, 6 months, 12 months, and annually through 5 years | |
| Secondary | Aortic-related death | formation, or aortic expansion | 1 month, 6 months, 12 months, and annually through 5 years | |
| Secondary | 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 | |
| Secondary | 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 |