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Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RelayPro | Experimental | Endovascular treatment with the investigational device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RelayPro | Device | Endovascular treatment with investigational device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Adverse Events (MAEs) | Primary safety endpoint is a composite of the following MAEs occurring through 30 days:
| 30 days |
| Technical success | Primary effectiveness rate as measured by the technical success through 24 hours, defined as:
| 24 hours |
| Stent graft patency | Primary effectiveness as measured by the rate of stent-graft patency through 12 months. | 12 months |
| Aneurysm rupture | Primary effectiveness as measured by the absence of aneurysm rupture through 12 months. | 12 months |
| Absence of Type I and III endoleak through 12 months; | Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months. | 12 months |
| Absence of stent fractures in the attachment zone through 12 months | Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months. | 12 months |
| Absence of open or endovascular secondary interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Loss of stent-graft patency | Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media. | 1 month and 6 months |
| Rate of aneurysm rupture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilson Szeto, MD | Penn Presbyterian | Principal Investigator |
| Venkatesh Ramaiah, MD | Arizona Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35241276 | Derived | Szeto WY, Vallabhajosyula P, Matsuda H, Moainie SL, Sharafuddin MJ, Corvera J, Smolock CJ, Miyamoto S, Naslund T, Ramaiah V; RelayPro-A Investigators. One-year results with a low-profile endograft in subjects with thoracic aortic aneurysm and ulcer pathologies. J Thorac Cardiovasc Surg. 2022 May;163(5):1739-1750.e4. doi: 10.1016/j.jtcvs.2021.10.071. Epub 2022 Feb 1. |
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Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
| 12 months |
| Absence of aneurysm expansion (> 5 mm diameter increase) | Primary effectiveness as measured by the absence of aneurysm expansion (> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study. | 12 months |
| Absence of stent-graft migration | Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT. | 12 months |
The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.
| 1 month and 6 months |
| Rate of endoleaks of all types | 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 will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media. | 1 month, 6 months and 12 months |
| Rate of 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 and 6 months |
| Incidence of open or endovascular secondary interventions | Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion). | 1 month and 6 months |
| Rate of aneurysm expansion | The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT | 1 month and 6 months |
| Rate of stent-graft migration | The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT. | 1 month and 6 months |
| Individual outcomes of composite MAEs | Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss >1,000 cc. | 6 months and 12 months |
| Rate of vascular access complications | Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system. | During the initial implant attempt |
| Duration of implant procedure | Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system. | Treatment Visit |
| Number of blood transfusions | Number of transfusions (units) required from the time of implant through hospital discharge. | Treatment Visit through Discharge Visit |
| Duration of hospitalization | Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure. | Treatment Visit through Discharge Visit |
| Time in Intensive Care Unit (ICU) | Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure. | Treatment Visit through Discharge Visit |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| University of California, Irvine | Irvine | California | 92868 | United States |
| Long Beach Memorial Hospital | Long Beach | California | 90806 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Heart Center | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospital and Clinic | Iowa City | Iowa | 52242 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center / Harvard Medical School | Boston | Massachusetts | 02215 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Medical Center / Penn Presbyterian | Philadelphia | Pennsylvania | 19104 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Centennial Heart & Vascular Institute Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Baylor Scott & White Medical Center - Plano The Heart Hospital | Plano | Texas | 75093 | United States |
| Baylor Scot & White Medical Center - Temple | Temple | Texas | 76508 | United States |
| Nagoya University Hospital | Nagoya | Aichi-ken | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | Japan |
| Teine Keihinkai Hospital | Sapporo | Hokkaido | Japan |
| Nara Medical University Hospital | Kashihara | Nara | Japan |
| Niigata University Medical & Dental Hospital | Niigata | Niigata | Japan |
| Oita University Hospital | Yufu | Oita Prefecture | Japan |
| Morinomiya Hospital | Joto-ku | Osaka | Japan |
| National Cerebral & Cardiovascular Center | Suita | Osaka | Japan |
| Jichi Medical University Saitama Medical Center | Ōmiya | Saitama | Japan |
| Jikei University Hospital | Minato-Ku | Tokyo | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | Japan |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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