RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Conditions
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Aortic Aneurysm, Thoracic, Penetrating Ulcer

Intervention / Treatment
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* Device: RelayPro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be ≥ 18 years of age Subject has specified disease in his/her descending thoracic aorta. Subject have anatomical compliance for the device specified for both access vessels and treatment area. Subject must be willing to comply with the follow-up evaluation schedule. Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment. Exclusion Criteria: Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm. Subject anatomy with significant stenosis, calcification, thrombus or tortuosity. Subjects with specified compromised circulation. Subjects with specified prior procedures. Subjects with allergy to contrast media or device components. Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure. Subjects that are pregnant or planning to become pregnant during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RelayPro<br>Endovascular treatment with the investigational device. | Device: RelayPro<br>* Endovascular treatment with investigational device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Adverse Events (MAEs) | Primary safety endpoint is a composite of the following MAEs occurring through 30 days: Death Stroke (excluding transient ischemic attack) Paralysis (excludes paraparesis) | 30 days | 
| Technical success | Primary effectiveness rate as measured by the technical success through 24 hours, defined as: Successful delivery of the device through the vasculature; Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis. | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |